[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"critical-illness\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:critical-illness":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,259,0,25,[9,49,81,105,127,150,182,207,245,270,306,332,360,395,422,443,474,497,525,552,574,603,636,664,690],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100652915","prevalence-and-measurement-of-delayed-gastric-emptying-in-patients-receiving-extracorporeal-membrane-oxygenation-100652915",false,"NCT07779174","Prevalence and Measurement of Delayed Gastric Emptying in Patients Receiving Extracorporeal Membrane Oxygenation","A Prospective Observational Study Exploring the Prevalence and Measurement of Delayed Gastric Emptying in Critically Ill Adults Receiving Extracorporeal Membrane Oxygenation","PROPEL-ECMO","* INCLUSION CRITERIA (non-ECMO group):\n\n  * Within 72 hours of Guy's \\& St Thomas' ICU admission\n  * Mechanically ventilated adults (≥18 years)\n  * Receiving enteral nutrition (liquid nutrition) via a gastric (nasogastric or orogastric) feeding tube\n  * Informed consent \u002F advice for participation by consultee\n  * Availability of study investigator or other trained healthcare professional on site to complete gastric emptying (stomach emptying) measurements\n* INCLUSION CRITERIA (ECMO group):\n\n  * Within 72 hours of Guy's \\& St Thomas' ICU admission\n  * Mechanically ventilated adults (≥18 years)\n  * Receiving enteral nutrition (liquid nutrition) via a gastric (nasogastric or orogastric) feeding tube\n  * Informed consent \u002F advice for participation by consultee\n  * Availability of study investigator or other trained healthcare professional on site to complete gastric emptying (stomach emptying) measurements\n  * Receiving either veno-venous or veno-arterial ECMO\n* EXCLUSION CRITERIA:\n\n  * Pregnancy\n  * History of gastroparesis (long-term slow stomach emptying)\n  * Current acute or long-term gastrointestinal pathology (stomach or bowel problem) that may influence gastric emptying (e.g. inflammatory bowel disease, coeliac disease, pancreatic exocrine insufficiency)\n  * Current contraindication to enteral nutrition (liquid nutrition) (e.g. clinical or radiological evidence of bowel obstruction, bowel ischaemia, ileus, upper gastrointestinal bleeding)\n  * Enteral nutrition (liquid nutrition) through a gastrostomy, jejunostomy or nasojejunal feeding tube\n  * Current or previous oesophageal, stomach or major small bowel surgery\n  * Known anatomical abnormality of the stomach (e.g. hiatus hernia)\n  * Pericardial \u002F abdominal drains or surgical wounds obstructing site of ultrasound scanning\n  * Nuclear medicine therapeutic administration, or diagnostic scintigraphy investigation in the previous 72 hours\n  * Unlikely to survive or withdrawal of life-sustaining treatment expected in the next 48 hours","ALL","18 Years","80 Years",{"count":22,"type":23},72,"ESTIMATED","OBSERVATIONAL","* The goal of this observational study is to learn whether the stomach takes longer to empty in patients on the intensive care unit who are receiving ECMO (a machine that temporarily takes over the role of the lungs and heart) compared to patients receiving support through a breathing machine (mechanical ventilation) only. It will also find the best way to measure stomach emptying at the bedside.\n* The main questions it aims to answer are:\n\n  * What is the prevalence of slow stomach emptying and other stomach or bowel problems in patients receiving ECMO, compared to patients receiving mechanical ventilation but not receiving ECMO? (Stage A)\n  * What is the best bedside method to measure stomach emptying in patients receiving ECMO? (Stage B)\n* Stage A of the study will involve measuring stomach emptying in study participants within four days of ICU admission, using two bedside methods:\n\n  * 'Residual volumes' (removing liquid nutrition left in the stomach with a syringe, after this has been given through the participant's usual feeding tube)\n  * A stomach ultrasound scan The researchers will check for differences between patients receiving ECMO versus no ECMO, and how this relates to the nutrition patients receive and how well or unwell they become in ICU.\n* In a smaller subgroup of patients receiving ECMO and participating in Stage B of the study, the researchers will also use scintigraphy. This is a standard research scan that tracks how the stomach empties by mixing a small, safe amount of radioactivity in the participant's usual liquid nutrition. The researchers will compare stomach emptying results from 'residual volumes' and stomach ultrasound with scintigraphy.",[27,28,29,30],"Gastric Emptying","Delayed Gastric Emptying","Critical Illness","ExtraCorporeal Membrane Oxygenation (ECMO)",[32,29,33,34,35],"Gastric emptying","Extracorporeal Membrane Oxygenation","Delayed gastric emptying","Nutrition","NOT_YET_RECRUITING","2026-08-19",{"date":39,"type":40},"2026-08-21","ACTUAL",{"date":42,"type":23},"2026-09",{"date":44,"type":23},"2028-06",{"name":46,"class":47},"Guy's and St Thomas' NHS Foundation Trust","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":48},"100652823","icu-succeed-for-survivors-of-acute-respiratory-failure-and-their-caregivers-100652823","NCT07778004","ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers","A Pilot Randomized Trial of the Self-Management Using Couples' Coping EnhancEment in Diseases Intervention for Survivors of Acute Respiratory Failure and Their Family Caregivers","ICU-SUCCEED","Patient Inclusion Criteria\n\n* Admitted to the medical ICU at UNC with acute respiratory failure (functional lung impairment resulting in hypoxia, hypercapnia, or both) and\u002For sepsis with significant end organ dysfunction.\n* At least 18 years old\n* Survives to hospital discharge\n* Is expected to be discharged home or to an acute inpatient rehabilitation center with a clear plan to be subsequently discharged home\n* Capable of providing written informed consent\n* Has English language proficiency\n\nCaregiver Inclusion Criteria\n\n* Provides emotional, physical, and\u002For financial support to the patient in a non-professional, unpaid capacity\n* Must be related to the patient in one of the following ways: a spouse or domestic partner, an adult child, a parent, or a sibling\n* At least 18 years of age\n* Has English language proficiency\n* Must be the caregiver of a patient that meets the patient eligibility criteria listed above\n\nPatient Exclusion Criteria:\n\n* No available family caregiver\n* Lacks decision-making capacity\n* Under 18 years of age\n* Living at a location other than home prior to admission\n* Unhoused prior to admission\n* Receives extracorporeal membrane oxygenation (ECMO) during hospital stay\n* Expected to discharge to any location other than home or an acute inpatient rehabilitation center\n* Does not have English language proficiency\n\nCaregiver Exclusion Criteria\n\n* Does not provide emotional, physical, and\u002For financial support to the patient in a non-profession, unpaid capacity\n* Is not related to the patient in one of the following ways: a spouse or domestic partner, an adult child, a parent, or a sibling\n* Cannot complete surveys or engage in other study activities due to physical or cognitive limitations\n* Unhoused prior to admission\n* Is under 18 years of age\n* Does not have English language proficiency\n* Is not the caregiver of a patient that meets the patient eligibility criteria listed above","99 Years",{"count":59,"type":23},144,"INTERVENTIONAL",[62],"NA","This study will investigate whether a family-centered intervention that has been adapted for patients with critical illness and their caregivers is possible, acceptable, and helpful",[65,29,66,67,68],"Acute Respiratory Failure","Sepsis","Hypoxia","Hypercapnia",[65,70,71,66,72],"Family-Centered Intervention","Critical illness","Septic shock","2026-08-18",{"date":39,"type":40},{"date":76,"type":23},"2026-09-01",{"date":78,"type":23},"2030-09-01",{"name":80,"class":47},"University of North Carolina, Chapel Hill",{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":60,"phases":92,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":48},"100597553","endogenous-energy-production-in-critically-ill-patients-100597553","NCT07059988","Endogenous Energy Production in Critically Ill Patients","The Effect of Nutrition on Endogenous Energy Substrate Production in the Early and Late Acute Phase of Critical Illness","eEPIC","Inclusion Criteria:\n\nFor the ICU group:\n\n1. ≥18 years old and admitted to the ICU\n2. Invasive mechanical ventilation\n3. Arterial and central line in situ\n4. Expected to remain in ICU \\>72 hours\n\nFor the control group:\n\n1\\. ≥18 years old\n\nExclusion Criteria:\n\n1. Lack of informed consent by patient\u002Fnext of kin\n2. Liver transplant\n3. Acute or acute on chronic liver failure\n4. Cirrhosis\n5. Known diabetes mellitus\n6. Pancreatic surgery\n7. Acute or chronic pancreatitis\n8. Pregnancy\n9. Intubated only for airway protection or neurologic deficit\n10. Mitochondrial disease\n11. Disorder of amino acid metabolism\n12. Familial hypertriglyceridemia\n13. Severe acquired hypertriglyceridemia (≥10 mmol\u002FL)\n14. Requiring treatment of hypoglycemia in the last 72 hours before inclusion.\n15. Requiring ongoing large volume resuscitation of crystalloids or blood products\n16. \\>72 hours in ICU before enrollment\n17. Readmission to ICU within 1 week of ICU discharge.\n18. Morbidly obese (BMI ≥35)\n19. Limitations of treatment to best supportive care\n20. Ongoing treatment with insulin\u002Fglucose related to hyperkalemia",true,{"count":91,"type":23},40,[62],"The aim of this study is to investigate when critically ill patients transition from a non-suppressible catabolism to a normal response to feeding.\n\nEndogenous production of glucose, fat and protein will be studied on a minimum of two occasions in mechanically ventilated ICU patients, in a fasted state and during parenteral nutrition. Substrate kinetics are estimated by a tracer dilution method using infusions of isotopically labeled glucose, glycerol and phenylalanine. Blood sampling for metabolomics analysis will be performed to elucidate potential biomarkers indicating an anabolic response to nutrition.",[29,95],"Metabolism and Nutrition Disorder","RECRUITING",{"date":98,"type":40},"2026-08-20",{"date":100,"type":40},"2025-07-14",{"date":102,"type":23},"2028-01",{"name":104,"class":47},"Karolinska University Hospital",{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":89,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":48},"100478706","ethnic-and-gender-based-admittance-patterns-in-the-icu-100478706","NCT05513456","Ethnic and Gender Based Admittance Patterns in the ICU","Ethnic and Gender Based Admittance Patterns in the ICU, a Multicenter, International Randomized Survey Study","EGAP-ICU","Inclusion Criteria:\n\nWe will include intensive care physicians, both in training and specialists as responders in this randomized survey study\n\nExclusion Criteria:\n\nWe will exclude \"button-mashers\", i.e. participating respondents that toggle through the case descriptions faster than they possibly could read the case description. A case answered \\\u003C20 seconds will be ruled out.",{"count":114,"type":23},5000,"The dominating proportion of patients in the ICU are men. Studies indicate that men receive more mechanical ventilation, vasoactive drugs, renal replacement therapy, invasive monitoring and have longer length of stay in the ICU. These differences do not unambiguously translate into a survival benefit for men; if survival would be altered if women were admitted to ICU in the same extent is unknown.\n\nFactors affecting ICU admission include age, co-morbidities, physiological parameters (indicating severity of the acute illness) and, additionally, the number of available ICU beds. Factors that should not affect ICU admission include patient gender or ethnicity.\n\nThis study aims at studying if bias against women and people of certain ethnicities exist. Do clinicians have differing thresholds for ICU admission due to non-medical reasons?\n\nThe investigators propose testing this hypothesis using a blinded randomized factorial survey study.",[29,117,118,119],"Gender Equality","Discrimination, Sex","Discrimination, Racial",{"date":98,"type":40},{"date":122,"type":40},"2024-05-31",{"date":124,"type":23},"2026-12",{"name":126,"class":47},"Karolinska Institutet",{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":60,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":4},"100619861","bis-in-icu-interventional-study-100619861","NCT07350122","BIS in ICU Interventional Study","Effect of BIS-Guided Sedation on Clinical Outcomes in Postoperative Cardiac Surgery ICU Patients: A Prospective, Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Undergoing cardiac surgery with subsequent admission to the intensive care unit (e.g., valve surgery, coronary artery bypass grafting, aortic surgery)\n* Planned or expected duration of invasive mechanical ventilation \\> 6 hours postoperatively\n* Requirement for continuous sedation during ICU stay\n\nExclusion Criteria:\n\n* Pre-existing neurological disorders affecting consciousness or sedation assessment (e.g., severe dementia, epileptic encephalopathy).\n* Acute neurological events in the perioperative period (e.g., stroke, intracranial hemorrhage).\n* Severe hepatic dysfunction (Child-Pugh Class C).\n* Participation in another interventional study potentially affecting sedation or cognitive outcomes.\n* Pregnancy or lactation.\n* Do-not-intubate (DNI)\u002FDo-not-resuscitate (DNR) orders or documented limitation of therapy.\n* Patients in whom short-term survival is deemed unlikely due to the clinical course.",{"count":59,"type":23},[62],"This study will test whether using a Bispectral Index (BIS) monitor to guide sedation can reduce the amount of sedative medication given to adults in the intensive care unit (ICU) after cardiac surgery. BIS is a non-invasive, EEG-based monitor that shows a number from 0-100 to reflect level of consciousness. Researchers will compare BIS-guided sedation to standard sedation guided by clinical scales (such as the Richmond Agitation-Sedation Scale, RASS).\n\nAbout 144 participants will be randomly assigned (1:1) to one of two groups at two hospitals in Austria (Medical University of Graz and Klinikum Wels-Grieskirchen). In the BIS group, clinicians will use BIS values and standard care to titrate sedation and will aim to avoid sustained BIS values below 50. In the control group, sedation will follow standard practices using clinical scales; BIS will be recorded but hidden from caregivers. The trial is open-label for treating staff; outcome assessors and data analysts will be blinded.\n\nParticipants will be in the study during their ICU sedation and mechanical ventilation period (typically more than 6 hours), with follow-up through ICU and hospital discharge. The primary outcome is the time-averaged dose of propofol (mg\u002Fkg\u002Fh) given during continuous ICU sedation until weaning (up to 72 hours). Secondary outcomes include duration of ventilation and sedation, depth of sedation measures, sedative and catecholamine doses, pulmonary infections (including ventilator-associated pneumonia), ICU and hospital length of stay, delirium, and in-hospital mortality.\n\nRisks are minimal and may include mild skin irritation from forehead electrodes. Possible benefits include improved sedation management; benefits are not guaranteed. Taking part is voluntary.",[138,29,139,140,141],"Cardiac Surgical Procedures (Postoperative Population)","Postoperative Complications (Cardiopulmonary)","Delirium - Postoperative","Pneumonia, Ventilator-Associated","2026-08-17",{"date":73,"type":40},{"date":145,"type":23},"2026-08",{"date":147,"type":23},"2027-07",{"name":149,"class":47},"Medical University of Graz",{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":159,"conditions":160,"keywords":165,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":48},"100640925","peripheral-pulse-assessment-and-arterial-pressure-pulsar-100640925","NCT07609095","Peripheral pULSe Assessment and Arterial pRessure (PULSAR)","Association Between Palpable Peripheral Pulses and Arterial Blood Pressure in Patients With Circulatory Shock: An International Prospective Multicenter Observational Cohort Study","PULSAR","Inclusion Criteria:\n\n* Clinical signs of circulatory shock or impending circulatory failure\n* Availability of non-invasive and\u002For invasive arterial blood pressure monitoring\n* Pulse palpation possible without interfering with emergency care\n\nExclusion Criteria:\n\n* Peripheral vascular conditions preventing reliable pulse palpation\n* Major extremity amputation affecting assessment sites\n* Clinical situations where study procedures interfere with life-saving treatment",{"count":114,"type":23},"This prospective multicenter observational study aims to investigate the relationship between palpable peripheral pulses and simultaneously measured arterial blood pressure in adult patients with circulatory shock or impending circulatory failure. Peripheral pulse palpation is routinely used in emergency medicine, trauma care, critical care, and cardiopulmonary resuscitation as a rapid clinical assessment of circulation. However, the association between palpable pulses and actual arterial blood pressure remains poorly validated.\n\nPatients treated in emergency departments, intensive care units, operating rooms, and other acute care settings will undergo routine pulse palpation at predefined anatomical locations including carotid, femoral, and radial arteries. Simultaneously measured non-invasive and\u002For invasive arterial blood pressure values will be recorded from routine clinical monitoring systems. Additional clinical variables relevant to circulatory status will also be collected.\n\nThe study seeks to define blood pressure thresholds associated with pulse palpability and evaluate the agreement between invasive and non-invasive blood pressure measurements in patients with circulatory shock.",[161,162,163,164,29],"Circulatory Shock","Hemodynamic Instability","Hypotension","Shock",[161,166,167,168,169,163,170,171,172,162],"Hemodynamic Monitoring","Pulse Palpation","Peripheral Pulse","Arterial Blood Pressure","Critical Care","Trauma","Resuscitation","2026-08-14",{"date":73,"type":40},{"date":176,"type":40},"2026-06-01",{"date":178,"type":23},"2031-12-31",{"name":180,"class":181},"Region Stockholm","OTHER_GOV",{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":191,"conditions":192,"keywords":195,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":203,"leadSponsor":205,"locationsCount":4},"100651668","ai-based-precision-transfusion-prediction-model-in-critically-ill-patients-100651668","NCT07762131","AI-Based Precision Transfusion Prediction Model in Critically Ill Patients","Artificial Intelligence-Based Precision Transfusion Prediction Model for Prevention of Multiple Organ Dysfunction Syndrome in Critically Ill Patients: A Multicenter Observational Study","Inclusion Criteria:\n\n* Adult patients (aged ≥18 years) admitted to the intensive care unit.\n* Patients with available clinical data, including demographic characteristics, laboratory parameters, transfusion-related information, and clinical outcomes.\n* Patients meeting the requirements for model development and analysis.\n\nExclusion Criteria:\n\n* Patients younger than 18 years.\n* Patients with missing key clinical information required for analysis.\n* Patients with repeated ICU admissions during the study period (only the first ICU admission will be included).\n* Patients whose data cannot be used for research purposes according to ethical requirements.",{"count":190,"type":23},2598,"This multicenter observational study aims to develop and validate an artificial intelligence-based precision transfusion prediction model for critically ill patients. The study will collect clinical characteristics, laboratory parameters, transfusion-related information, physiological data, and clinical outcomes from critically ill patients admitted to intensive care units. An AI model will be developed using retrospective data and further evaluated using prospective observational data. The primary objective is to investigate factors associated with multiple organ dysfunction syndrome (MODS) and establish a predictive model to support individualized transfusion management in critically ill patients.",[29,193,194],"Multiple Organ Dysfunction Syndrome","Blood Transfusion",[196,197,198,193],"Artificial Intelligence","Precision Transfusion","Critically Ill Patients","2026-08-11",{"date":201,"type":40},"2026-08-13",{"date":76,"type":23},{"date":204,"type":23},"2029-09-01",{"name":206,"class":47},"Second Affiliated Hospital, Zhejiang University, School of Medicine",{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":60,"phases":218,"briefSummary":219,"conditions":220,"keywords":221,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":48},"100651370","physiological-changes-in-adult-intensive-care-patients-following-contact-with-their-primary-caregiver-100651370","NCT07761364","Physiological Changes in Adult Intensive Care Patients Following Contact With Their Primary Caregiver","Physiological Changes in Adult Intensive Care Patients Upon Contact With Their Primary Caregiver (CARE-ICU): A Randomized Clinical Trial","CARE-ICU","Inclusion Criteria\n\nPatient Criteria:\n\n* Adults aged 18 years or older.\n* Admission to the intensive care unit (ICU) for 24 to 48 hours.\n* Richmond Agitation-Sedation Scale (RASS) score between -3 and -1 or between 0 and +3.\n* Glasgow Coma Scale score greater than 13.\n\nPrimary Caregiver Criteria:\n\n* Identified as the patient's primary caregiver.\n* Willing and able to participate in the study.\n* Provides written informed consent prior to study participation.\n\nExclusion Criteria\n\nPatient Criteria:\n\n* Diagnosis of a neurological disorder (e.g., cerebrovascular disease or stroke).\n* Multiple organ dysfunction syndrome (MODS).\n* Unstable or difficult-to-control cardiac arrhythmias.\n* Fever (body temperature ≥ 37.5°C) at the time of assessment.\n* Hypertension (blood pressure ≥ 130\u002F80 mmHg) at the time of assessment.\n\nPrimary Caregiver Criteria:\n\n\\- Unable to be present to perform the intervention according to the study protocol.","59 Years",{"count":217,"type":23},80,[62],"Patients admitted to intensive care units are exposed to multiple environmental and clinical factors that may affect their physiological responses. This randomized controlled trial aims to evaluate the effect of physical contact with the primary caregiver on physiological parameters in adult patients hospitalized in an intensive care unit.",[29,198],[222,29,198,223,224,225,226,227,228,229,230,231,232,233,234,235],"Intensive Care Unit","Primary Caregiver","Family Caregive","Therapeutic Touch","Physical Contact","Human Touch","Physiological Parameters","Physiological Response","Heart Rate","Blood Pressure","Respiratory Rate","Oxygen Saturation","Critical Care Nursing","Patient-Centered Care","2026-08-10",{"date":238,"type":40},"2026-08-12",{"date":240,"type":40},"2026-08-01",{"date":242,"type":23},"2026-08-31",{"name":244,"class":47},"Universidad Autonoma del Estado de Mexico",{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":18,"minAge":253,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":60,"phases":257,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":48},"100533285","phase-2-azithromycin-for-critical-asthma---pediatrics-100533285","NCT06223828","Azithromycin for Critical Asthma - Pediatrics","Azithromycin as Immunomodulation Among Children Hospitalized for Critical Asthma: A Prospective, Open-Label, Non-Randomized, Interventional Study With Parallel Biospecimen Banking","CR-AZI Kids","Inclusion criteria\n\n* Age 3-17 years\n* Admission to the PICU\n* Primary diagnosis of critical asthma\n* Prescription for continuous inhaled beta-agonist therapy and\u002For intravenous (IV) beta-agonist therapy\n* Prescription for intravenous systemic corticosteroids\n\nExclusion criteria\n\n* Critical Congenital Heart Disease Unrepaired\n* Tracheostomy Dependence at Admission\n* Ongoing Exposure to Azithromycin or Macrolide Antibiotics for any indication\n* Past Medical History of Prolonged QT Syndrome or Arrhythmias\n* Concomitant respiratory pathology including Acute Chest Syndrome, Interstitial Lung Disease, Cystic Fibrosis, and pulmonary hypertension","3 Years","17 Years",{"count":256,"type":23},100,[258,259],"PHASE2","PHASE3","The CR-AZI Study will assess the immunomodulatory effects of Azithromycin for pediatric Critical Asthma.",[262,29],"Pediatric Asthma",{"date":199,"type":40},{"date":265,"type":40},"2024-04-02",{"date":267,"type":23},"2027-06-30",{"name":269,"class":47},"Johns Hopkins All Children's Hospital",{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":60,"phases":279,"briefSummary":280,"conditions":281,"keywords":288,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":304,"locationsCount":48},"100641181","compare-vent-feasibility-pilot-study-100641181","NCT07656259","COMPARE-VENT Feasibility Pilot Study","COMPARE-VENT Feasibility Pilot Study: A Pragmatic Cluster Randomized Crossover Trial for Ventilation Strategies and Hemodynamic Impact in Critically Ill Patients With Cardiovascular Disease","Inclusion Criteria:\n\nEligible adults ≥ 18 years of age admitted to the cardiac ICU with need for invasive mechanical ventilation of expected duration \\>12 hours.\n\nPre-Specified Subgroups for exploratory outcomes:\n\n1. SCAI Stages C-E Cardiogenic Shock\n2. Mechanical circulatory support use, including intra-aortic balloon pumps and microaxial flow pumps, including Impella CP, RP Impella Flex, and Impella 5.5 devices\n3. Heart failure with reduced ejection fraction: LVEF \\\u003C40% or;\n4. Moderate to severe RV systolic dysfunction or;\n5. Moderate to severe Pulmonary hypertension, as defined by ACC\u002FAHA\u002FESC guidelines\n\nExclusion Criteria:\n\n1. Expected duration of intubation \\\u003C12 hours.\n2. Severe COPD, bronchopleural fistulas, or severe ARDS (Berlin criteria P\u002FF \\\u003C100, in the absence of pulmonary edema)\n3. Home ventilator or chronic tracheostomy.\n4. Pregnant, incarcerated, patients or those receiving extracorporeal membrane oxygenation",{"count":278,"type":23},75,[62],"Cardiac disease complicated by respiratory insufficiency comprises the most frequent indication for cardiac intensive care unit (CICU) admission, with nearly one-third patients requiring advanced respiratory support and over 20% patients requiring invasive mechanical ventilation (IMV). IMV among patients with impaired cardiovascular reserve is further compounded by the adverse impact of positive pressure ventilation (PPV) and systemic sedation on intracardiac hemodynamics, pulmonary vascular mechanics and consequently end-organ perfusion. Despite widespread use, evidence guiding optimal ventilatory practices and mode selection in cardiovascular intensive care unit patients remains limited. Pressure-controlled and volume-controlled ventilation may differ in their effects on patient-ventilator synchrony, sedation requirements, and hemodynamic impact, but comparative data among patients with critical cardiac disease remains inconclusive. This pilot study will evaluate the feasibility of implementing a pragmatic cluster-randomized crossover trial comparing ventilatory modes in a contemporary cardiovascular intensive care unit.",[282,283,284,29,285,286,287],"Respiration Failure","Cardio Vascular Disease","Cardiogenic Pulmonary Oedema","Mechanical Ventilation","Cardiogenic Shock","Cardiopulmonary",[289,290,291,292,293,71,294,295,296,297,298],"Cardiovascular disease","Cardiac arrest","Cardiogenic shock","Respiratory failure","Cardiopulmonary interactions","Intensive care unit","Critical care therapies","Outcomes","Mechanical ventilation","Positive pressure ventilation","2026-08-05",{"date":236,"type":40},{"date":302,"type":40},"2026-07-01",{"date":267,"type":23},{"name":305,"class":47},"Mayo Clinic",{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":89,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":60,"phases":316,"briefSummary":317,"conditions":318,"keywords":321,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":329,"leadSponsor":331,"locationsCount":48},"100649851","ketosis-immune-function-and-metabolic-adaptation-in-response-to-short-term-fasting-in-critical-illness-100649851","NCT07738536","Ketosis, Immune Function and Metabolic Adaptation in Response to Short-term Fasting in Critical Illness","KETOsis, Immune Function and Metabolic Adaptation in Response to Short-Term Fasting in Critical Illness (KETO-FAST): A Translational Substudy of the FAST-ICU Cluster-randomized Cross-over Trial.","KETO-FAST","Inclusion Criteria:\n\n1. Adult (≥18 years).\n2. ICU admission (index admission to the participating ICU).\n\nExclusion Criteria:\n\n1. The patient requires intravenous glucose infusion, enteral nutrition or parenteral nutrition according to the attending clinician's assessment,\n2. Acute or acute-on-chronic liver failure\n3. Moderate hypernatremia ( \\>150 mmol\u002FL)\n4. Diabetic ketoacidosis or hyperosmolar hyperglycemic state at admission,\n5. Pregnancy,\n6. Exclusive end-of-life care (no other treatment goal than comfort care for end of life),\n7. Organ donor,\n8. Prior enrolment in this trial during the same hospitalisation,\n9. Patients with a metabolic disease requiring specific diet and patients with clinical need for a ketogenic diet.\n10. Patients already enrolled in other interventional studies on nutrition, intravenous fluids, phosphate supplementation or hormonal therapies that influence glucose homeostasis.\n11. Inclusion not possible due to site-specific regulatory issues regarding the ethical approval or informed consent procedure.",{"count":315,"type":23},200,[62],"KETO-FAST is a pre-planned translational substudy of the FAST-ICU cluster-randomized cross-over trial. The substudy will characterize ketone body production and associated metabolic, autophagy-related, and immune cellular responses during the first 72 hours after intensive care unit admission in critically ill patients exposed to delayed nutrition compared with patients receiving standard care.\n\nPatients enrolled in FAST-ICU at designated participating centers will undergo serial blood sampling during the first 72 hours after ICU admission. Plasma ketone body concentrations, targeted metabolomics, serum-induced cellular responses in vitro, leukocyte autophagy markers, and immune cell phenotypes and functional markers will be assessed. In addition, 10 healthy volunteers will perform a 72-hour fast with blood sampling to provide reference values from non-critically ill subjects.",[29,319,320,35],"Fasting State","Ketosis",[170,322,323,320,324],"Intensive care","Fasting","Calorie restriction","2026-07-29",{"date":327,"type":40},"2026-07-31",{"date":242,"type":23},{"date":330,"type":23},"2027-07-31",{"name":104,"class":47},{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":60,"phases":340,"briefSummary":341,"conditions":342,"keywords":344,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":48},"100649528","optimizing-dysphagia-treatment-delivery-in-acute-care-a-hybrid-efficacy-implementation-trial-100649528","NCT07736105","Optimizing Dysphagia Treatment Delivery in Acute Care: A Hybrid Efficacy Implementation Trial","Inclusion criteria for critically ill adults will be:\n\n1. Adult ≥ 18 years old\n2. Not pregnant\n3. Underwent a clinical flexible endoscopic evaluation of swallowing (FEES) or videofluoroscopy swallow study (VFSS) with a penetration aspiration scale (PAS) score ≥ 5\n4. Hospitalized in non-neuro intensive care unit (ICU) setting at Vanderbilt University Medical Center (VUMC) at some point during admission\n5. Dysphagia is primarily related to ICU stay and not other medical conditions that may cause dysphagia\n6. medically cleared with no contraindications for expiratory muscle strength training (EMST) or other treatments\n7. Cognitive capacity to follow basic directions\n8. Willing to undergo testing and treatment for the study.\n\nInclusion criteria for speech-language pathologists (SLPs) will be:\n\n1. Adult acute care speech-language pathologist who works at VUMC.\n2. Willing to complete surveys and\u002For participate in a focus group.",{"count":339,"type":23},120,[62],"This research study is investigating the efficacy and implementation of expiratory muscle strength training (EMST), standard of care dysphagia treatment, and intensive dysphagia treatment in critically ill adults in the acute care setting. Currently, no targeted, effective, and feasible dysphagia treatment approaches currently exist for use in critically ill adults in the acute care setting. The current study will investigate the impact of EMST, standard of care dysphagia treatment, and intensive dysphagia treatment on pulmonary function, cough function, swallow function, frailty, patient-reported swallow function, and health outcomes in critically ill adults. This study will also examine patient perceptions and clinical speech-language pathologists' perceptions of the acceptability, appropriateness, and feasibility of these interventions.\n\nCritically ill adults will: undergo tests of breathing, cough, and swallow function, complete questionnaires about the treatment, and their swallow function, and complete their respective treatment as prescribed.\n\nClinical speech-language pathologists will complete questionnaires about the interventions.\n\nA subset of critically ill adults and clinical speech-language pathologists will also have the opportunity to participate in focus groups.",[343,29],"Dysphagia",[343,345,346,347,348,349,350,29,351],"Swallowing","Deglutition","Deglutition Disorders","Swallowing Disorders","Breathing","Cough","Treatment",{"date":353,"type":40},"2026-07-30",{"date":355,"type":23},"2027-04",{"date":357,"type":23},"2029-02",{"name":359,"class":47},"Vanderbilt University Medical Center",{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":18,"minAge":367,"maxAge":254,"enrollmentInfo":368,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":370,"conditions":371,"keywords":376,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":391,"leadSponsor":393,"locationsCount":48},"100637740","brain-blood-flow-and-cerebral-autoregulation-monitoring-in-critically-ill-children-100637740","NCT07613918","Brain Blood Flow and Cerebral Autoregulation Monitoring in Critically Ill Children","Transcranial Doppler Assessment of Cerebral Autoregulation and Blood Flow Velocity Patterns in Critically Ill Children: A Prospective Observational Study","Inclusion Criteria:\n\n* Has at least one Parent or Legal Guardian who is willing and able to provide informed consent in English\n* Mechanically ventilated (Endotracheal tube)\n* Indwelling arterial catheter\n* Current patient in the American Family Children's Hospital PICU.\n* 1 day to 17.5 years of age\n\nExclusion Criteria:\n\n* Subjects with a known or obvious anatomic barrier preventing safe application of the transcranial Doppler probe (e.g., cranial dressings, cranial fixation hardware, ventricular access devices positioned over insonation sites, or bilateral craniectomies)\n* Patient with known chronic hypertension\n* Admission FSS score \\> 16\n* Tracheostomized patient\n* The designated sub-investigator (Dr. Talal Al Hendawi) and PI (Dr. Neil Munjal) are unavailable to perform the Transcranial Doppler scan at the time of eligibility. All study scans are performed by either Dr. Al Hendawi or Dr.Munjal to ensure standardization and data integrity. Therefore, if they are unavailable (e.g., due to clinical service, leave, or other scheduling constraints), the patient will not be enrolled in the study.\n* Not suitable for study participation due to other reasons at the discretion of the investigators","1 Day",{"count":369,"type":23},125,"This study uses a non-invasive (external) ultrasound test called Transcranial Doppler (TCD) to measure how blood flows through the major arteries of the brain of children receiving care in the Pediatric Intensive Care Unit (PICU). TCD is already used for clinical reasons in many children, but it is not part of routine monitoring for every critically ill child. By using TCD, the investigators hope to better understand how brain blood flow changes during illness. They will also track children's functional status from before their illness to the time of PICU discharge to explore how brain blood flow patterns relate to neurological outcomes.125 participants will be enrolled and will be on study while in the PICU, estimated to be 3-14 days.",[29,372,373,374,375],"Pediatric Critical Illness","Respiratory Failure","Traumatic Brain Injury","Cardiac Arrest",[377,378,379,380,381,382,383,384,385,386,387,388],"PICU","infant","Transcranial Doppler Assessment","Cerebral Autoregulation","Blood Flow Velocity","children","mechanical ventilation","neurocritical care","pulsatility index","Mean flow index","neonate","pediatric critical care",{"date":353,"type":40},{"date":145,"type":23},{"date":392,"type":23},"2028-05",{"name":394,"class":47},"University of Wisconsin, Madison",{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":18,"minAge":253,"maxAge":19,"enrollmentInfo":402,"targetDuration":4,"studyType":60,"phases":404,"briefSummary":405,"conditions":406,"keywords":408,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":418,"leadSponsor":420,"locationsCount":48},"100650015","remote-exercise-program-for-pediatric-icu-survivors-100650015","NCT07741942","Remote Exercise Program for Pediatric ICU Survivors","Feasibility Study of a Remote Exercise Intervention Program for Preventing Post-Intensive Care Syndrome in Pediatric Critical Illness Survivors","Inclusion Criteria:\n\n* Age 3 to 18 years.\n* Discharged from the pediatric intensive care unit (PICU) after at least 48 hours of treatment.\n* Has not recovered to the pre-PICU level of physical function (walking and mobility), confirmed using the Pediatric Overall Performance Category Scale (POPC) and the Gross Motor Function Classification System Family Report Questionnaire (GMFCS Family Report).\n* Has sufficient cognitive and physical ability to understand and participate in the home-based exercise intervention.\n* Able to maintain adequate attention for exercise training, assessed using the Richmond Agitation-Sedation Scale (RASS) and age-appropriate delirium assessment (psCAM-ICU or pCAM-ICU), when applicable.\n* Written informed consent provided by the parent or legal guardian.\n\nExclusion Criteria:\n\n* Newly developed neuromuscular disease after PICU admission that prevents participation in the video-based exercise program without therapist assistance.\n* Medical conditions, indwelling catheters, or implanted medical devices requiring restriction of limb movement.\n* Language or cognitive impairment that prevents understanding of the video-based exercise program.\n* Uncontrolled hypertension, arrhythmia, persistent fever due to infection, or any condition making exercise unsafe.\n* Declines to participate in the study.",{"count":403,"type":23},10,[62],"This pilot clinical trial aims to evaluate the feasibility and safety of a remote exercise intervention program designed to prevent pediatric post-intensive care syndrome (PICS-p) in children discharged from the pediatric intensive care unit (PICU). Children aged 3 to 18 years who received intensive care for at least 48 hours and have not recovered to their pre-admission functional status will participate in an individualized home-based exercise program for 12 weeks. The intervention includes remotely supervised exercise sessions, prescribed self-exercise, and weekly monitoring using videoconferencing. Study assessments will be performed at baseline, immediately before intervention initiation, monthly during the 12-week intervention, and 1 month after completion of the intervention to evaluate feasibility, safety, functional recovery, and maintenance of treatment effects.",[407,29],"Pediatric Post-Intensive Care Syndrome",[409,410,411,412,413],"Pediatric intensive care unit","Post-intensive care syndrome","Remote exercise","Telerehabilitation","Pediatric rehabilitation","2026-07-28",{"date":416,"type":40},"2026-08-03",{"date":42,"type":23},{"date":419,"type":23},"2027-03",{"name":421,"class":47},"Seoul National University Hospital",{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":430,"targetDuration":432,"studyType":24,"phases":4,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":435,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":442},"100649772","peripheral-perfusion-index-trajectory-to-predict-28-day-mortality-in-patients-with-sepsis-in-the-intensive-care-unit-100649772","NCT07740304","Peripheral Perfusion Index Trajectory to Predict 28-Day Mortality in Patients With Sepsis in the Intensive Care Unit","Peripheral Perfusion Index Trajectory as a Predictor of 28-Day Mortality and Its Incremental Value Over SOFA and Lactate in Patients With Sepsis and Septic Shock: A Prospective Observational Cohort Study","PERFUSE-ICU","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of sepsis or septic shock according to Sepsis-3 criteria (suspected or confirmed infection with an acute increase in SOFA score of 2 points or more)\n* Enrollment possible within the first 6 hours of intensive care unit admission\n* Written informed consent obtained from the patient or, when the patient lacks decision-making capacity, from a legal representative, in accordance with the approved consent procedure\n\nExclusion Criteria:\n\n* Conditions precluding valid peripheral perfusion measurement at both measurement sites, including severe peripheral arterial disease, limb ischemia or amputation, extensive edema or burns, or local trauma at the measurement site\n* Intensive care unit stay of 24 hours or longer at another facility prior to admission\n* Decision to withdraw or limit life-sustaining treatment planned within the first 24 hours\n* Pregnancy\n* Severe Raynaud phenomenon or vasospastic disease of the extremities\n* Persistent tremor or agitation precluding standardized measurement\n* Concurrent enrollment in an interventional study",{"count":431,"type":23},400,"90 Days","Sepsis is a life-threatening condition caused by the body's overwhelming response to infection, and it remains a leading cause of death in intensive care units. Even when standard treatment targets such as blood pressure are met, blood flow to the small vessels of the skin and other tissues may remain impaired. This \"hidden\" poor perfusion may not be detected by routine monitoring, yet it may be linked to worse outcomes.\n\nThe perfusion index is a simple number obtained from the standard pulse oximeter already placed on a patient's finger. It reflects blood flow in the peripheral tissues, requires no additional procedure, and causes no discomfort.\n\nThis prospective observational cohort study will examine whether the perfusion index, and especially how it changes over the first 24 hours in the intensive care unit, can help predict death within 28 days in adults with sepsis or septic shock. Capillary refill time and skin mottling score will be recorded as additional bedside measures of peripheral perfusion.\n\nNo treatment will be changed for the purpose of this study, and no additional blood samples or invasive procedures will be performed. All care decisions remain with the treating team. Measurements will be taken at intensive care admission and at 6 and 24 hours. Participants will be followed for 28 days, with survival status also recorded at 90 days.\n\nThe study will be conducted at two centers. A prediction model will be developed in the first center and then tested, without modification, in patients enrolled at the second center.",[66,29],{"date":327,"type":40},{"date":437,"type":40},"2026-07-06",{"date":439,"type":23},"2027-10-07",{"name":441,"class":47},"Trakya University",2,{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":60,"phases":453,"briefSummary":454,"conditions":455,"keywords":458,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":48},"100649592","effect-of-structured-education-for-family-members-of-intensive-care-patients-undergoing-tracheostomy-100649592","NCT07737353","Effect of Structured Education for Family Members of Intensive Care Patients Undergoing Tracheostomy","The Effect of Structured Education Provided to Family Members of Patients Undergoing Tracheostomy in the Intensive Care Unit on Anxiety, Psychological Well-Being, and Satisfaction With Care: A Randomized Controlled Trial","TRACH-FAMILY","Inclusion Criteria:\n\n* Family member or primary caregiver of a patient scheduled to undergo tracheostomy in one of the participating intensive care units.\n* Aged 18 years or older.\n* Able to read, understand, and communicate in Turkish.\n* Willing to participate in the study.\n* Provides written informed consent.\n* Actively involved in the patient's care and treatment process.\n\nExclusion Criteria:\n\n* Diagnosed with a severe psychiatric disorder.\n* Severe hearing, visual, or cognitive impairment that prevents completion of the study questionnaires.\n* Communication problems that prevent participation in the data collection process.\n* Declines to participate in the study.",{"count":452,"type":23},84,[62],"Family members of patients undergoing tracheostomy in the intensive care unit frequently experience anxiety, uncertainty, and concerns regarding the patient's care. This randomized controlled trial aims to evaluate the effect of structured education provided to family members of patients undergoing tracheostomy in the intensive care unit on state anxiety, psychological well-being, and satisfaction with care. Participants will be randomly assigned to either the intervention or control group. The intervention group will receive structured education before tracheostomy, whereas the control group will receive routine information. Outcomes will be assessed before tracheostomy, on the first day after tracheostomy, and one week after the procedure.",[456,29,457],"Tracheostomy","Intensive Care",[459,460,222,456,461,462,463,464,465],"Structured Education","Family Members","Anxiety","Psychological Well-Being","Satisfaction With Care","Family-Centered Care","Randomized Controlled Trial","2026-07-27",{"date":353,"type":40},{"date":469,"type":40},"2026-05-18",{"date":471,"type":23},"2027-05-18",{"name":473,"class":47},"Giresun University",{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":482,"conditions":483,"keywords":485,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":493,"leadSponsor":495,"locationsCount":4},"100649378","cost-effectiveness-of-inhaled-sedation-versus-intravenous-propofol-in-mechanically-ventilated-critically-ill-adults-100649378","NCT07734350","Cost-Effectiveness of Inhaled Sedation Versus Intravenous Propofol in Mechanically Ventilated Critically Ill Adults","Cost-effectiveness of Inhaled Sedation Versus Intravenous Propofol in Mechanically Ventilated Critically Ill Patients: a Retrospective ICU Study","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Admission to the intensive care unit at Hospital H+ Querétaro\n* Invasive mechanical ventilation for at least 24 hours\n* Receipt of inhaled sedation or continuous intravenous propofol sedation during ICU stay\n\nExclusion Criteria:\n\n* Extracorporeal membrane oxygenation\n* Severe traumatic brain injury\n* Transfer to another hospital unit\n* Less than 24 hours of mechanical ventilation",{"count":431,"type":23},"The goal of this observational study is to learn whether inhaled sedation is a cost-effective alternative to intravenous propofol in mechanically ventilated critically ill adults admitted to the intensive care unit. The main questions it aims to answer are:\n\n* Does inhaled sedation reduce the total cost of care compared with intravenous propofol?\n* Does inhaled sedation reduce the duration of mechanical ventilation and ICU length of stay?\n* Are adverse events different between patients receiving inhaled sedation and those receiving intravenous propofol?\n\nResearchers will compare patients who received inhaled sedation with patients who received intravenous propofol to see if inhaled sedation improves clinical outcomes and reduces overall costs.\n\nParticipants will:\n\n* Be identified through review of electronic medical records\n* Be included if they are adults who received mechanical ventilation and were sedated with inhaled sedation or intravenous propofol\n* Contribute data on total costs of care, duration of mechanical ventilation, ICU length of stay, and adverse event",[29,285,484],"Respiratory Insufficiency",[486,487,297,71,294,488,489,490],"Inhaled sedation","Propofol","Cost-effectiveness","Critical care sedation","Adult ICU patients",{"date":325,"type":40},{"date":325,"type":23},{"date":494,"type":23},"2026-10-31",{"name":496,"class":47},"Hospital H+ Queretaro",{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":504,"minAge":505,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":508,"conditions":509,"keywords":514,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":523,"locationsCount":48},"100572088","ultrasound-detection-of-body-composition-in-critical-care-100572088","NCT06728722","Ultrasound Detection of Body Composition in Critical Care","Detection of the Changes in Body Composition of Critically Ill Obstetrics by Ultrasound and the Co-relations With Clinical Outcomes; a Prospective Observational Study.","Inclusion Criteria:\n\n* females with age 16 with no upper limit\n* American Society of Anesthesiologists (ASA) class I, II or III,\n* admitted to the obstetrics and Gynecology critical care unit\n\nExclusion Criteria:\n\n* Patient refusal","FEMALE","16 Years",{"count":507,"type":23},121,"Objective assessment of the Changes in body composition of critically ill patients is very valuable. Ultrasound stands as a solution due to its portability, bedside availability, and radiation-free technology. Those criteria are crucial for critically ill obstetrics and gynecological cases.",[510,511,29,512,513],"Muscle Loss","Extracellular Fluid Alteration","Pregnancy Complications","Gynecologic Disease",[515,516,517,518],"ultrasound","body composition","critical illness","peripartum and gynecological cases",{"date":414,"type":40},{"date":521,"type":40},"2024-12-15",{"date":76,"type":23},{"name":524,"class":47},"Ain Shams University",{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":60,"phases":535,"briefSummary":536,"conditions":537,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":551},"100561314","improving-needs-among-older-adults-100561314","NCT06588556","Improving Needs Among Older Adults","Improving Needs Among Older Adults: the ICUconnect 2 Primary Palliative Care RCT","ICUconnect 2","Inclusion Criteria:\n\nPatients (who are not interviewed but whose characteristics prompt enrollment of family members)\n\n1. Adult aged ≥18 years\n2. Managed in an adult medical, cardiac, trauma, surgical, or neurological ICU\n3. Serious acute illness associated with a need for invasive mechanical ventilation\n4. ICU team expect patient to require mechanical ventilation for 2 or more days\n\nFamily members\n\n1. Adult aged ≥18 years\n2. Family member: self-described as the individual (related or unrelated) who provides the most support and with whom the eligible patient has a significant relationship (Society of Critical Care Medicine definition of family; Davidson J, et al. Crit Care Med, 45:103-128; 2017)\n\nICU clinicians\n\n1. Adult aged ≥18 years\n2. ICU clinician: ICU attending caring for the eligible patient on the day of family member informed consent\n\nExclusion Criteria:\n\nPatients\n\n1. Death or full comfort care plan expected within 24 hours by ICU attending or fellow physician Rationale: measurable intervention effect unlikely\n2. Palliative care consultative team and\u002For palliative care specialists are currently involved in the patient's care.\n\n   Rationale: this would dilute the intervention's effect.\n3. ICU length of stay \\>4 days during current ICU admission. Rationale: this would dilute intervention effect by widening the timeframe of family-clinician interactions and limiting standardization.\n\n6\\. Imprisoned person. Rationale: this is a vulnerable population.\n\nFamily members\n\n1. Low palliative care need burden (i.e., NEST scale score \\\u003C15) at baseline. Rationale: if there are very low baseline needs, the intervention cannot impact the primary outcome measure (i.e., NEST).\n2. Lack of English or Spanish fluency, operationalized as need for a translator to understand medical forms or participate in medical discussions.\n\n   Rationale: the app has not been translated into other languages; also, many outcome measures aren't validated in languages other than English and Spanish.\n3. Endorsement of suicidal ideation (i.e., PHQ-9 suicidality item) at the time of baseline data collection.\n\n   Rationale: this indicates a serious level of distress that will require professional assistance beyond that provided by the intervention (or control).\n4. Patient regains decisional capacity after informed consent but before the first family meeting. Rationale: as in our past ICU-based studies, this circumstance (the entry of the patient as a decision maker), would substantially change the nature of the interactions of family members and clinicians.\n5. The ICU clinician changes from a consented clinician to a non-consented clinician before the first family meeting. Rationale: in this circumstance the intervention cannot be fully deployed.\n\nICU clinicians None",{"count":534,"type":23},350,[62],"Millions of older adults receive care in intensive care units (ICUs) annually. However, the quality and accessibility of ICU-based palliative care is highly variable across hospitals and clinicians, due in part to specialists' limited workforce and geographic inconsistency. To address these gaps, the investigators developed an innovative mobile app-based primary palliative care intervention called ICUconnect. ICUconnect facilitates families' and patients' self-report of actual palliative care needs across all core domains of palliative care quality, provides ICU clinicians with a scalable digital infrastructure for coordinating consistent and personalized needs-targeted care, and provides a variety of informational supports relevant to each user's role. In this RCT, the investigators will test ICUconnect vs. usual care control among 350 patient-family member dyads with elevated baseline levels of unmet palliative care need in a 4-site network serving a diverse population (Duke, Medical University of South Carolina, University of Alabama at Birmingham, Columbia).\n\nThe specific aims are to: (1) Test the efficacy of ICUconnect vs. usual care control in improving palliative care needs and other person-centered outcomes including psychological distress, (2) Determine participant characteristics associated with a greater treatment response using a heterogeneity of treatment effects approach, and (3) Ensure off-the-shelf intervention readiness for implementation using a mixed-methods integration of qualitative analysis of semi-structured trial participant interviews and quantitative RE-AIM implementation framework-informed trial data.",[29,538,539,540,541],"Palliative Care","Older Adults","Informal Caregivers","Care Delivery Model","2026-07-22",{"date":544,"type":40},"2026-07-23",{"date":546,"type":40},"2025-09-16",{"date":548,"type":23},"2028-12-31",{"name":550,"class":47},"Duke University",4,{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":556,"acronym":4,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":558,"targetDuration":367,"studyType":24,"phases":4,"briefSummary":559,"conditions":560,"keywords":561,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":48},"100648588","assessment-of-hemodynamic-responses-at-adequate-depth-of-anesthesia-using-bispectral-index-during-rapid-sequence-intubation-in-the-emergency-department-100648588","NCT07722897","Assessment of Hemodynamic Responses at Adequate Depth of Anesthesia Using Bispectral Index During Rapid Sequence Intubation in the Emergency Department","Inclusion Criteria:\n\nAdults aged 18 years or older. Patients undergoing rapid sequence intubation (RSI) in the emergency department.\n\nPatients in whom bispectral index (BIS) monitoring can be applied before laryngoscopy.\n\nPatients achieving an adequate depth of anesthesia (BIS 45-55) before laryngoscopy.\n\nWritten informed consent obtained from the patient or a legally authorized representative, when applicable according to local ethics requirements.\n\nExclusion Criteria:\n\nAge \\\u003C18 years. Cardiac arrest before or during induction. Patients requiring immediate (\"crash\") intubation without sufficient time for BIS monitoring.\n\nInability to obtain reliable BIS monitoring (e.g., technical failure or inability to place the sensor).\n\nPregnancy. Facial or scalp conditions preventing BIS sensor placement. Prisoners or other vulnerable populations if excluded by the ethics protocol.\n\n\\-",{"count":315,"type":23},"Rapid sequence intubation (RSI) is the standard approach for emergency airway management in critically ill patients requiring endotracheal intubation. Laryngoscopy and tracheal intubation may provoke significant hemodynamic responses, including increases in heart rate and blood pressure, which may adversely affect patients with severe neurological or cardiovascular disease.\n\nAlthough hemodynamic responses during tracheal intubation have been extensively investigated in the anesthesiology literature, evidence from emergency department settings remains limited. Furthermore, previous studies have rarely confirmed whether an adequate depth of anesthesia had been achieved before laryngoscopy, making interpretation of hemodynamic responses difficult.\n\nThe aim of this prospective observational study is to evaluate hemodynamic responses during rapid sequence intubation in adult emergency department patients after confirming adequate depth of anesthesia using bispectral index (BIS) monitoring. Heart rate and blood pressure will be recorded before induction, during intubation, and after successful endotracheal intubation, allowing objective assessment of the hemodynamic response under confirmed adequate anesthetic depth.",[29],[562,563,564,565],"Rapid Sequence Intubation","Emergency Department","Bispectral Index","Hemodynamic Response","2026-07-20",{"date":544,"type":40},{"date":569,"type":40},"2026-05-01",{"date":571,"type":23},"2028-05-01",{"name":573,"class":47},"Akdeniz University Hospital",{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":580,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":60,"phases":584,"briefSummary":585,"conditions":586,"keywords":590,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":596,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":48},"100648300","enteral-nutrition-and-colonization-resistance-through-microbiota-modulation-in-critically-ill-patients-100648300","NCT07719673","Enteral Nutrition and Colonization Resistance Through Microbiota Modulation in Critically Ill Patients","Enteral Nutrition to Enhance Colonization Resistance Through Gut Microbiota Modulation in Critically Ill Patients: A Randomized Controlled Pilot Trial","MICRON","Inclusion Criteria:\n\n* Patients with medical (non-surgical) conditions admitted to the ICU.\n* ICU admission within the previous 48 hours at the study site.\n* Initiation of enteral nutrition within the first 48 hours after ICU admission.\n* Written informed consent obtained for participation in the study.\n\nExclusion Criteria:\n\n* Surgical ICU patients.\n* Patients in whom enteral nutrition was not initiated within the first 48 hours after - ICU admission.\n* Patients with galactosemia.\n* Patients with major contraindications to enteral nutrition, including: intestinal obstruction, intestinal ischemia, intestinal perforation, severe hemodynamic instability, patients who refuse participation in the study.",{"count":583,"type":23},60,[62],"The goal of this clinical trial is to learn whether enteral nutrition enriched with fiber can influence gut microbiota and improve resistance to colonization with multidrug-resistant bacteria in critically ill patients. The study will also evaluate the safety and clinical outcomes associated with fiber-enriched enteral nutrition.\n\nThe main questions it aims to answer are:\n\n* Does fiber-enriched enteral nutrition reduce the acquisition of colonization with multidrug-resistant bacteria during intensive care unit (ICU) hospitalization?\n* Does fiber-enriched enteral nutrition modify the composition and diversity of the intestinal microbiota?\n* Are there differences in clinical outcomes, including adverse events, between patients receiving fiber-enriched and non-fiber enteral nutrition?\n\nResearchers will compare patients receiving fiber-enriched enteral nutrition with patients receiving standard enteral nutrition without added fiber to determine whether fiber supplementation influences gut microbiota and colonization resistance.\n\nParticipants will:\n\n* Receive enteral nutrition through a feeding tube according to their clinical needs.\n* Receive either a fiber-enriched enteral nutrition formula or a standard enteral nutrition formula.\n* Have stool samples collected during ICU hospitalization for analysis of intestinal microbiota and detection of multidrug-resistant bacteria.\n* Be monitored for clinical outcomes, infections, antibiotic exposure, and adverse events during their ICU stay and follow-up period.",[587,588,29,589],"Bacterial Colonization","Multidrug Resistant Organisms","Gut Microbiota Dysbiosis",[591,592,593,594,595],"enteral nutrition","bacterial colonization","multidrug resistant organisms","gut microbiota","critical care",{"date":542,"type":40},{"date":598,"type":23},"2026-10",{"date":600,"type":23},"2027-12",{"name":602,"class":47},"Iuliu Hatieganu University of Medicine and Pharmacy",{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":609,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":613,"conditions":614,"keywords":619,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":631,"completionDateStruct":632,"leadSponsor":634,"locationsCount":4},"100647520","analysis-of-weaning-of-analgosedation-and-kinetics-of-emergence-in-critically-ill-patients-100647520","NCT07710066","Analysis of Weaning of Analgosedation and Kinetics of Emergence in Critically Ill Patients","AWAKE-ICU: Analysis of Weaning of Analgosedation and Kinetics of Emergence in Critically Ill Patients","AWAKE-ICU","Inclusion Criteria:\n\nAdult critically ill patients with acute respiratory failure or requiring invasive mechanical ventilation in the context of critical illness will be consecutively enrolled. Eligible participants must meet all of the following criteria:\n\n* Age ≥18 years.\n* Receiving invasive mechanical ventilation for ≥24 hours.\n* Prior exposure to continuous analgosedation before undergoing a first valid Structured Awakening Evaluation (SAE) during the ICU stay, as defined by the study's operational criteria.\n* Availability of sufficient clinical information to identify the baseline time point (t0) and characterize the first valid Structured Awakening Evaluation according to the study's operational definitions.\n* Provision of informed consent for participation in the study.\n\nExclusion Criteria:\n\n1. Acute primary structural brain injury in which the level of consciousness is primarily determined by the neurological condition or constitutes a therapeutic target, including but not limited to:\n\n   * Moderate or severe traumatic brain injury.\n   * Subarachnoid hemorrhage.\n   * Ischemic or hemorrhagic stroke.\n   * Central nervous system infections.\n   * Other structural brain injuries requiring therapeutic sedation or goal-directed intensive neurological monitoring.\n2. Ongoing therapeutic sedation for neurological indications at the time of the first valid Structured Awakening Evaluation (SAE), including:\n\n   * Intracranial hypertension management.\n   * Status epilepticus.\n   * Other neuroprotective strategies requiring deep sedation.\n3. ICU admission following cardiac arrest with return of spontaneous circulation and suspected hypoxic-ischemic brain injury or the need for targeted therapeutic sedation.\n4. Insufficient clinical information to accurately identify the baseline time point (t0) and characterize the architecture of the first valid Structured Awakening Evaluation.\n5. Patients receiving extracorporeal life support (ECLS\u002FECMO), in whom assessment of hemodynamic and respiratory stability before initiation of awakening and liberation from invasive mechanical ventilation is substantially more complex.",{"count":612,"type":23},500,"The goal of this prospective multicenter observational study is to characterize early trajectories of consciousness recovery following the first valid structured awakening trial in mechanically ventilated critically ill adults, a phase that is not captured by current weaning classifications.\n\nThe main questions it aims to answer are:\n\n1. What trajectories of consciousness recovery occur during the first 72 hours after the first valid structured awakening trial?\n2. Are different early consciousness trajectories associated with clinically relevant outcomes, including successful liberation from mechanical ventilation, delirium, duration of mechanical ventilation, ventilator-free days, mortality, and long-term functional and cognitive outcomes?\n\nParticipants will:\n\n1. Undergo standardized serial assessments of consciousness during the first 72 hours after the first valid structured awakening trial using the Richmond Agitation-Sedation Scale (RASS) and a standardized motor command assessment.\n2. Receive daily assessments for delirium and weaning-related outcomes during the ICU stay.\n3. Be followed for clinical outcomes during hospitalization and for functional and cognitive recovery up to 1 year after ICU admission.",[29,285,615,616,617,618],"Weaning Invasive Mechanical Ventilation","Sedation and Analgesia","Critical Care Medicine","Delirium",[620,621,622,285,623,624,625,626,627],"Emergence from Analgosedation","Structured Awakening Evaluation","Recovery of Consciousness","Richmond Agitation-Sedation Scale (RASS)","Motor Command Assessment","Consciousness Trajectories","Mechanical Ventilation Weaning","Delayed Awakening","2026-07-16",{"date":630,"type":40},"2026-07-17",{"date":76,"type":23},{"date":633,"type":23},"2028-09-01",{"name":635,"class":47},"Patricia Rodriguez Villamizar",{"id":637,"slug":638,"hasResults":12,"nctId":639,"briefTitle":640,"officialTitle":641,"acronym":642,"eligibilityCriteria":643,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":644,"targetDuration":4,"studyType":60,"phases":646,"briefSummary":647,"conditions":648,"keywords":650,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":657,"lastUpdatePostDateStruct":658,"startDateStruct":659,"completionDateStruct":660,"leadSponsor":662,"locationsCount":4},"100644647","multimodal-sleep-promotion-in-surgical-icu-patients-100644647","NCT07672509","Multimodal Sleep Promotion in Surgical ICU Patients","Multimodal Sleep Promotion Intervention in Adult Postoperative Intensive Care Unit Patients: Two-Center Non-Randomized Controlled Pilot Study","MULTISLEEP","Inclusion Criteria:\n\n* Adult patients aged 18 years or older.\n* Patients admitted to an adult intensive care unit after surgery.\n* Expected ICU stay of at least one night.\n* Patients with clinical stability and adequate pain control allowing participation in the intervention and completion of study assessments.\n* Patients able to understand and complete the questionnaires, either independently or with minimal assistance.\n* Patients without language barriers that prevent study participation.\n\nExclusion Criteria:\n\n* Patients with acute neurological impairment or moderate to severe cognitive dysfunction.\n* Patients receiving invasive mechanical ventilation with ongoing sedation.\n* Patients with a severe pre-existing sleep disorder requiring specific treatment not available in the ICU setting.\n* Patients unable to provide questionnaire responses due to communication limitations or clinical condition.\n* Patients with language barriers preventing participation in study procedures and completion of study assessments",{"count":645,"type":23},50,[62],"Sleep disturbances are highly prevalent among patients admitted to intensive care units (ICUs). Critical illness, environmental factors, and routine clinical care frequently result in fragmented sleep, reduced sleep quality, and disruption of normal circadian rhythms. Previous studies have shown that poor sleep in ICU patients may be associated with delirium, impaired recovery, decreased functional outcomes, and lower patient satisfaction.\n\nEnvironmental factors such as noise generated by alarms and medical equipment, continuous light exposure, frequent nursing interventions, pain, anxiety, and discomfort related to invasive devices have been identified as major contributors to sleep disruption in critically ill patients. Several non-pharmacological interventions, including earplugs, eye masks, environmental modifications, and nursing care bundles, have demonstrated potential benefits in improving sleep quality. However, most studies have focused on isolated interventions, and evidence regarding comprehensive multimodal approaches remains limited.\n\nThis two-center non-randomized controlled pilot study aims to evaluate the effectiveness of a multimodal sleep promotion intervention in adult postoperative ICU patients. The intervention combines individualized sleep hygiene education, provision of earplugs and eye masks, environmental measures to reduce nighttime noise and light exposure, and reorganization of nursing care activities to minimize unnecessary sleep interruptions. Patients admitted to the intervention ICU will receive the multimodal sleep promotion program, while patients admitted to the control ICU will receive usual care.\n\nThe primary objective is to assess the effect of the intervention on patient-reported sleep quality. Secondary objectives include evaluating patient experience during ICU stay and exploring the relationship between sleep outcomes and selected demographic and clinical variables. The findings of this pilot study will provide preliminary evidence regarding the feasibility and effectiveness of multimodal sleep promotion strategies in adult ICU settings and may support the development of future larger-scale studies.",[649,29],"Sleep Wake Disorders",[651,652,653,654,655,656],"Sleep Quality","ICU Patients","Sleep Promotion","Sleep Hygiene","Patient Experience","Humanization of Care","2026-07-15",{"date":628,"type":40},{"date":76,"type":23},{"date":661,"type":23},"2027-01-30",{"name":663,"class":47},"Fundación de investigación HM",{"id":665,"slug":666,"hasResults":12,"nctId":667,"briefTitle":668,"officialTitle":669,"acronym":4,"eligibilityCriteria":670,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":671,"enrollmentInfo":672,"targetDuration":4,"studyType":60,"phases":674,"briefSummary":675,"conditions":676,"keywords":678,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":682,"lastUpdatePostDateStruct":683,"startDateStruct":684,"completionDateStruct":686,"leadSponsor":688,"locationsCount":48},"100647842","humidification-effects-on-airway-complications-and-clinical-outcomes-in-trauma-icu-patients-on-mechanical-ventilation-100647842","NCT07713238","Humidification Effects on Airway Complications and Clinical Outcomes in Trauma ICU Patients on Mechanical Ventilation","Effect of Active Versus Passive Humidification on Airway Complications and Clinical Outcomes in Trauma ICU Patients With Prolonged Mechanical Ventilation","Inclusion Criteria\n\n1. Adult age 18-65 years.\n2. Trauma ICU patients receiving invasive mechanical ventilation.\n3. Anticipated to require prolonged mechanical ventilation, defined as ≥7 days of invasive ventilatory support\n\nExclusion Criteria:\n\n1. Immunosuppression such as HIV, cancer or AIDS.\n2. Blood leukocyte count \\\u003C1,000 cells\u002Fmm3.\n3. Withdrawal of life-sustaining treatment within 5 days.\n4. Use of HME in conjunction with an HH.\n5. Contraindications of HME including body temperature \\\u003C 32°C, copious, thick, or bloody secretions, significant air leak (exhaled VT \\>70% of VT inspired) or broncopleural fistula","65 Years",{"count":673,"type":23},162,[62],"This study compares the effects of two primary airway humidification methods-active heated humidifiers (HHs) and passive heat-and-moisture exchangers (HMEs)-on trauma intensive care unit (ICU) patients requiring prolonged mechanical ventilation. Adequate humidification is essential during mechanical ventilation because artificial airways bypass the body's natural ability to warm and moisten inhaled air. While existing guidelines show no overall superiority of one method over the other in general ICU populations, trauma patients present unique challenges, such as thick or bloody secretions, which may lead to airway obstructions and affect the performance of these devices.\n\nThe main purpose of this randomized controlled trial is to evaluate how active versus passive humidification impacts airway complications (such as secretion viscosity and tube obstruction) and clinical outcomes (including ventilator-associated pneumonia, duration of mechanical ventilation, length of ICU stay, and mortality rates). A total of 162 adult trauma patients at Assiut University Hospital will be randomly assigned to either the HH group or the HME group to determine if there are significant clinical differences between the two methods in this specific patient population.",[484,677,29],"Wounds and Injuries",[679,680,681,285],"Heated Humidifier","Heat and Moisture Exchanger","Airway Complications","2026-07-14",{"date":566,"type":40},{"date":685,"type":23},"2026-07-12",{"date":687,"type":23},"2027-05-12",{"name":689,"class":47},"Assiut University",{"id":691,"slug":692,"hasResults":12,"nctId":693,"briefTitle":694,"officialTitle":695,"acronym":696,"eligibilityCriteria":697,"healthyVolunteers":12,"sex":18,"minAge":698,"maxAge":699,"enrollmentInfo":700,"targetDuration":4,"studyType":60,"phases":702,"briefSummary":704,"conditions":705,"keywords":708,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":713,"lastUpdatePostDateStruct":714,"startDateStruct":715,"completionDateStruct":717,"leadSponsor":719,"locationsCount":720},"100600757","phase-1-pk-safety-and-preliminary-efficacy-study-of-montelukast-in-critically-ill-infants-with-developing-bronchopulmonary-dysplasia-100600757","NCT07101640","PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia","Pharmacokinetics, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia","PRISM","Inclusion Criteria\n\n1. Documented informed consent from parent or guardian, prior to study activities\n2. Receiving mechanical ventilation \\[high frequency or conventional\\] and requiring supplemental oxygen (FiO2 ≥ 30%) at time of randomization\n3. \\\u003C28 weeks' gestational age and \\\u003C1000 g bodyweight at birth\n4. 7 to 28 (inclusive) days postnatal age at the time of first study drug dose\n5. Able to tolerate 5 mL of enteral volume\n\nExclusion Criteria\n\n1. Previous enrollment and dosing in the current PRISM study (NICHD-2023-MON01)\n2. Previous exposure to montelukast within 7 days prior to randomization\n3. Known allergy to montelukast\n4. PI deems infant - prior to enrollment - is not expected to survive\n5. Has a disease complication that would preclude safe participation of the participant\n6. Increased respiratory support due to intercurrent illness (e.g., sepsis, necrotizing enterocolitis, etc.). Infants should be excluded from the study until after resolution of the acute event\n7. Congenital lung and diaphragmatic malformations","7 Days","28 Days",{"count":701,"type":23},28,[703,258],"PHASE1","The purpose of the study is to learn how safe montelukast may be in premature infants at significant risk for Bronchopulmonary Dysplasia (BPD) and to determine how much and how quickly montelukast moves from the stomach into the bloodstream, and how quickly it is removed from the bloodstream.\n\nData supporting the prospect of montelukast benefit involved 6 previous studies involving 206 preterm infants. The dosing ranged from 0.5 to 2.5 mg\u002Fkg\u002Fday, which aligns with the proposed initial dose of 0.75 mg\u002Fkg\u002Fday. Though each previous study had a small population, collectively they reveal montelukast as a promising drug in populations of preterm infants developing BPD and for individual preterm infants who are \"developing BPD.\" Thus, researchers expect clinical benefit for preterm infants in this study.\n\nDespite the benefit-to-risk ratio presented by these previous studies, the optimal dose remains to be determined; thus, this study design and PK analysis will start with the lowest dose that is likely to provide direct benefit to participants.",[706,707,29],"Bronchopulmonary Dysplasia (BPD)","Premature Births",[709,710,711,712],"PK","Pharmacokinetics","bronchopulmonary dysplasia","montelukast","2026-07-13",{"date":682,"type":40},{"date":716,"type":40},"2026-02-23",{"date":718,"type":23},"2028-06-30",{"name":550,"class":47},5]