Critical Illness

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. Critically 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. Clinical speech-language pathologists will complete questionnaires about the interventions. A subset of critically ill adults and clinical speech-language pathologists will also have the opportunity to participate in focus groups.

Mechanical insufflation-exsufflation (MI-E) is an established airway clearance technique for patients with chronic conditions like neuromuscular diseases. However, its use in critically ill ICU patients remains inconsistent and lacks standardized guidelines. Despite growing research, current practices vary widely in patient selection, treatment protocols, and safety management, with limited high-quality evidence to support clear recommendations. To address this gap, an international, multidisciplinary Delphi consensus study is needed to establish expert-based best practices and feasible guidelines for the safe and effective implementation of MI-E in the intensive care setting.

Summary of the Research on Withdrawing and Withholding Life-Sustaining Treatment for Critically Ill Children Background Medical treatments require regular evaluation to ensure they align with the patient's best interests, particularly in intensive care where quality of life is often compromised. In the context of critically ill children, the challenge increases as patients may not be fully conscious or capable of expressing their needs and preferences. While intensive care can extend life, end-of-life situations necessitate careful consideration to avoid providing futile treatments that do not benefit the patient. Decision-Making Complexity Identifying when further treatment is beneficial poses significant challenges, influenced by various factors including the wishes of the patient and guardians. Previous studies indicate variability among healthcare providers in treatment decisions, often stemming from personal experiences and emotional responses. However, comparable research focusing on critically ill children in Nordic contexts remains scarce. Medical decisions often require balancing potential benefits against the risks of extended suffering or loss of valuable time at the end of life. A previous survey on end-of-life care in Europe indicated similar attitudes across regions but highlighted the need for cultural considerations. Sweden's distinct social and cultural values, characterized by individualism and secularism, may influence practices surrounding life-sustaining treatment. Research Aims This research aims to investigate the factors affecting decision-making regarding the withdrawal and withholding of life-sustaining treatments for critically ill children in Swedish and Nordic intensive care units (ICUs). It will examine practitioners' experiences, attitudes, and the relative impact of children's autonomy in these decisions, excluding neonatal care. Key scientific questions focus on Physicians' attitudes and challenges regarding treatment withdrawal. Methodology Semi-structured interviews in multiple ICUs to explore ethical dilemmas faced by physicians.

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). About 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. Participants 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/kg/h) 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. Risks 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.

This is a prospective observational physiopathological study aimed at evaluating the immunological and inflammatory determinants associated with the prognosis of patients admitted to intensive care units (ICU). The study will establish multidimensional models predicting one-year survival and the occurrence of nosocomial infections. Patients admitted to ICU undergo routine biological sampling. In addition to these, minimal supplementary samples will be collected for immunological and inflammatory biomarker analysis at admission, day 1, day 4, day 8, ICU discharge or day 28, and at 12 months. Additional samples may be taken during clinically significant events (nosocomial infections, complications).

Sleep disturbance is very common among critically ill patients in the intensive care unit (ICU), particularly in older adults after surgery. Poor sleep in the ICU is associated with important complications, including delirium, longer duration of mechanical ventilation, prolonged hospital stay, and increased mortality. Current non-drug approaches to improve sleep, such as reducing noise and light and clustering nursing care, may provide limited benefit and are often difficult to implement consistently. Safe and effective drug treatments for sleep in critically ill older patients remain limited. Lemborexant is a dual orexin receptor antagonist that promotes sleep by blocking wake-promoting pathways in the brain. Unlike many traditional sleep medications, lemborexant has minimal effects on breathing and has been shown to be well tolerated in older adults with insomnia. However, its effects on sleep and delirium have not been studied in critically ill patients. This study is a single-center, randomized, double-blind, placebo-controlled feasibility and pilot trial conducted in the surgical intensive care unit of Siriraj Hospital, Bangkok, Thailand. The study will enroll 100 critically ill postoperative patients aged 65 years or older who are expected to remain in the ICU for at least 48 hours. Participants will be randomly assigned to receive either low-dose lemborexant (2.5 mg) or a matching placebo once nightly for three consecutive nights. All participants will also receive standard non-pharmacologic sleep-promoting care used in the ICU. The main goals of this pilot study are to evaluate the feasibility and safety of administering lemborexant in elderly ICU patients and to explore its potential effects on sleep and delirium. Sleep will be assessed using both subjective questionnaires completed each morning and objective wrist-worn actigraphy to measure sleep duration and sleep stages. Delirium will be assessed twice daily using a standardized delirium screening tool for up to seven days or until ICU discharge. Additional outcomes include medication adherence, adverse events, duration of mechanical ventilation, length of ICU and hospital stay, and in-hospital mortality. The results of this study will provide important preliminary data on the feasibility, safety, and potential benefits of lemborexant in critically ill older adults and will help inform the design of future larger clinical trials aimed at improving sleep and reducing delirium in the ICU.

Accurate measures of kidney function is important for precision dosing of many medications. The current methods of determining kidney function largely hinge on the use of equations that use common laboratory values such as serum creatinine \& static variables like age \& weight. These are helpful for trending over time, but often are inaccurate during times of medical illness. Other more accurate methods of measuring kidney function include urine collection, although this is not commonly used because of various reasons that make the collection inconvenient or unreliable. The new transdermal glomerular filtration (tGFR) device permits accurate, real-time evaluation of kidney function. This novel method has not been rigorously compared with urine collection \& other methods of determining kidney function in hospitalized patients. The goal of the study is to compare tGFR with other accepted methods of determining kidney function.

Among critically ill patients, many die, and many of the survivors and their family members struggle for years with reduced quality of life. Critically ill patients are treated in intensive care units (ICUs). Here, they receive life support, e.g., mechanical ventilation and advanced support of the circulation (heart and blood vessels) and kidneys. In addition, ICU patients receive many other treatments. It is, however, uncertain if all the treatments provide value for the patients. The desirable effects of many treatments are uncertain, and some may be wasteful or even harmful. Clinical trials are necessary to validly assess the desirable and undesirable effects of different treatments. However, conventional clinical trials have limitations: * They typically only assess a single question related to a single comparison of treatments at a time. * They are often not very flexible, including with regards to the number of participants needed, and this increases the risk that a trial will end up as inconclusive. * There is no or limited re-use or sharing of infrastructure across trials, leading to duplicate work and resource use. * Trial participants do usually not benefit from the obtained knowledge before the trial concludes. * Involvement of patients, family members, and other stakeholders is typically limited, which may decrease the relevance of the questions addressed. With the Intensive Care Platform Trial (INCEPT), we aim to tackle these challenges by establishing a flexible platform trial that continuously learns from the obtained results. The platform trial may run forever with simultaneous and continuous assessment of many treatments. INCEPT will continuously learn from the accrued data and use these to improve the treatment of both participating and future patients. With INCEPT, we are also building a framework for thorough and extensive involvement of key stakeholders, including patients and family members. INCEPT will improve the way clinical trials are done and increase the probabilities that treatments are improved. This will: * Directly improve outcomes for ICU patients. * Relieve a strained healthcare system by discarding inefficient or harmful treatments. * Ensure that new treatments are beneficial or cost-effective before implementation. * Lower the costs and burdens of assessing more treatments in the critically ill.

This study aims to investigate whether acupuncture, specifically a combination of body acupuncture and ear vagus nerve stimulation (taVNS), can improve gastrointestinal function in critically ill elderly patients in the Intensive Care Unit (ICU). Gastrointestinal motility problems, such as delayed stomach emptying and constipation, are common in elderly ICU patients and can interfere with feeding, increase infection risk, and worsen outcomes. This research will test if adding acupuncture to standard care helps patients tolerate tube feeding (enteral nutrition) faster, reduces the need for intravenous nutrition, and improves overall recovery. Participants will be randomly assigned to one of three groups: standard care alone, standard care plus body acupuncture, or standard care plus both body acupuncture and ear vagus nerve stimulation. The study will compare the time it takes to achieve target feeding goals, changes in gastrointestinal function scores, and other clinical outcomes. This single-center, prospective, randomized controlled trial will enroll 60 elderly patients from the Geriatric ICU of Jiangsu Province Hospital and aims to provide evidence for integrating traditional Chinese medicine into critical care practice.

This prospective observational cohort study aims to evaluate the predictive performance of the Pediatric Sequential Organ Failure Assessment (pSOFA) score for mortality and selected clinical outcomes among critically ill children admitted to the Pediatric Intensive Care Unit (PICU). A total of 100 children will be enrolled and followed during their PICU stay.

The goal of this retrospective observational study is to learn how well three simple trauma scores predict death during the hospital stay in adults admitted to intensive care after an injury in Tunisia. The scores are the Glasgow Coma Scale, Age, and Systolic Blood Pressure score (GAP); the Mechanism, Glasgow Coma Scale, Age, and Systolic Blood Pressure score (MGAP); and the New Trauma Score for Triage (T-NTS). Researchers will review existing medical records for admissions from 1 January 2018 through 31 December 2025. They will not assign treatment or contact participants. The main question is how accurately the three scores distinguish participants who died in the hospital from those discharged alive. Secondary analyses will examine agreement between score-based risk and observed mortality and performance for mortality by day 7 after ICU admission.

Critically ill patients admitted to intensive care units (ICUs) frequently develop elevated blood sugar levels (hyperglycemia) as a result of acute illness-related stress, even if they do not have diabetes. While high blood glucose in the ICU is known to be associated with complications such as acute kidney injury and increased mortality, absolute glucose measurements alone may not distinguish acute stress from pre-existing chronic elevation. The Stress Hyperglycemia Ratio (SHR) evaluates the relative increase in blood glucose by dividing admission plasma glucose by the patient's estimated background average glucose derived from glycated hemoglobin (HbA1c). This measurement reflects the intensity of acute physiologic stress adjusted for baseline glycemic control. The purpose of this prospective observational study is to evaluate the prognostic utility of admission Stress Hyperglycemia Ratio in adult critically ill patients admitted to the intensive care units of Assiut University Hospitals. The study aims to determine whether admission SHR can predict in-hospital ICU mortality, acute kidney injury (AKI), the severity of acute organ failure measured by Sequential Organ Failure Assessment (SOFA) scores, the requirement and duration of invasive mechanical ventilation and vasopressor support, and the overall length of ICU stay. All participants will receive standard clinical care in accordance with institutional ICU protocols; no experimental drugs or clinical interventions will be administered as part of this study.

This study aims to evaluate the effect of ventilator hyperinflation combined with body positioning on arterial blood gases in patients with ventilator-associated pneumonia. Forty-two mechanically ventilated patients will be randomly assigned into two groups receiving the intervention in either supine or lateral decubitus positions. Arterial blood gases will be assessed over a 6-day intervention period. The findings are expected to provide evidence regarding the optimal positioning strategy to enhance the effectiveness of ventilator hyperinflation in improving gas exchange in critically ill patients.

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. The 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. This 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. No 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. The 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.

The overarching goal of this study is to support the "real world" assessment of strategies used to foster adoption of several highly efficacious evidence-based practices in healthcare systems that provide care to critically ill adults with known health disparities. Investigators will specifically evaluate two discrete strategies grounded in behavioral economic and implementation science theory (i.e., real-time audit and feedback and registered nurse implementation facilitation) to increase adoption of the ABCDEF bundle in critically ill adults.

This prospective observational cohort study aims to characterize feeding intolerance in critically ill adult patients and to identify clinical, physiological, laboratory, electrophysiological, and imaging factors associated with its development. Within 24 hours after intensive care unit (ICU) admission, participants undergo systematic multimodal assessment, including blood sampling, gastrointestinal electrophysiological measurements, gastric antral ultrasonography with assessment of antral motility, skeletal muscle ultrasonography, intra-abdominal pressure measurement, and collection of relevant clinical and laboratory variables. Participants are prospectively followed for the occurrence of feeding intolerance and other clinically relevant outcomes. The study will evaluate the incidence, predictors, and risk factors of feeding intolerance and explore whether multimodal measurements obtained within the first 24 hours after ICU admission can improve early prediction of feeding intolerance compared with conventional clinical variables. Additional outcomes include duration of organ support, ICU-free days, ventilator-free days, mortality at 28, 90, and 180 days, and longer-term health-related quality of life assessed using the EQ-5D-5L. The overall objective is to improve understanding of feeding intolerance in critically ill patients, enable early risk stratification, and provide a theoretical basis for future individualized nutritional assessment and management strategies.

The goal of this clinical trial is to investigate the impact of a ventilation strategy with a lower respiratory rate (RR) (permissive lung-protective ventilation) on clinical outcomes in adult critically ill patients receiving invasive ventilation. The main question it aims to answer is: Is a permissive lung-protective ventilation, defined as a strategy that reduces ventilatory intensity by stepwise lowering RR to the lowest level permitted by predefined safety limits, superior to conventional lung-protective ventilation, with respect to the number of days free from ventilation and alive at day 28 (VFD-28) in adult critically ill patients receiving invasive ventilation? Researchers will compare permissive lung-protective ventilation with conventional lung-protective ventilation to see if it improves clinical outcomes. Participants will be randomly assigned to one of the two ventilation strategies under investigation and followed up for 28 days.

This study evaluates the effect of driving pressure optimization on right ventricular-pulmonary artery (RV-PA) coupling, assessed by TAPSE/PASP ratio, and its association with acute kidney injury (AKI) progression in mechanically ventilated critically ill patients.

Pulse oximeters are widely used in intensive care to continuously estimate the oxygen level in the blood. However, pulse oximeter measurements may be less accurate when blood flow to the fingers is poor, which is common in critically ill patients. This study will investigate whether warming the hand and lower part of the forearm can improve the accuracy of pulse oximeter measurements in mechanically ventilated adult intensive care patients with low blood flow to the fingers. Participants will be randomly assigned to either a local warming strategy or usual care without warming. In the warming group, the hand and lower forearm will be warmed for 15 minutes to a target temperature of 41-42°C. Pulse oximeter measurements will be compared with oxygen saturation measured from an arterial blood sample before and after the intervention. The main objective is to determine whether local warming reduces the difference between pulse oximeter oxygen saturation (SpO₂) and arterial oxygen saturation (SaO₂) 15 minutes after the start of the assigned strategy. The study will also assess whether any improvement persists at 60 minutes, how peripheral blood flow changes during 4 hours of follow-up, whether repeat warming is effective when blood flow decreases again, and whether the effect differs according to skin phototype. Safety related to the warming intervention will also be evaluated.

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, representing one of the leading causes of death in intensive care units (ICUs) worldwide. Gut microbiota disruption is increasingly recognized as a key driver of persistent inflammation and multiple organ dysfunction in septic patients. Fecal microbiota transplantation (FMT) has emerged as a promising approach to restore gut microbial homeostasis. This study hypothesizes that FMT acts not through long-term engraftment of donor microbes, but via a "functional pulse" - a potent, transient biological intervention that delivers high-dose microbial metabolites (e.g., short-chain fatty acids), competitively inhibits pathogens, and rapidly modulates intestinal immune cell functions. This is a single-center, open-label, randomized controlled trial conducted in the ICU of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. A total of 60 adult patients diagnosed with sepsis according to Sepsis-3 criteria within 24 hours of ICU admission will be randomized in a 1:1 ratio to receive either ICU standard care alone (control group) or ICU standard care plus FMT administered via a nasojejunal tube for three consecutive days (intervention group). The primary endpoint is all-cause mortality at 90 days. Secondary endpoints include ICU mortality, in-hospital mortality, 28-day mortality, changes in gut microbiota composition and metabolites, serum citrulline levels as a marker of intestinal barrier function, Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, vasopressor requirements, C-reactive protein and procalcitonin levels, fluid balance, incidence of ICU delirium and feeding intolerance, and 90-day hospital readmission rate. Safety outcomes include gastrointestinal symptoms and transient fever.

SHANTI-ICU compares the effectiveness of two evidence-based multicomponent ICU sleep promotion bundles on delirium and patient-reported sleep quality in critically ill adults. Bundle A is a non-pharmacologic strategy. Bundle B includes all components of Bundle A plus pharmacist-led pharmacologic strategies. Sixteen intensive care units across eight hospitals implement one of the two bundles as a unit-level change to routine care, using a concurrent multiple-intervention stepped wedge randomized design. The primary outcome is delirium incidence, measured using the Confusion Assessment Method for the ICU (CAM-ICU) as documented during routine clinical care. Secondary outcomes are delirium duration, ICU length of stay, nightly patient-reported sleep quality, and overall patient-reported ICU sleep quality. Patients receive the assigned bundle as part of routine care. The study operates under an IRB-approved waiver of informed consent and waiver of HIPAA authorization; there is no individual enrollment procedure.

In patients with critical illness, such as severe infections, heart attacks, or respiratory failure, most intensive care units (ICUs) measure magnesium levels and give supplemental doses of magnesium when levels are below certain targets. However, the best targets are unknown. The goal of this clinical trial is to study protocols for magnesium supplementation in people with critical illness, comparing a protocol with higher target level to a protocol with a lower target level. The main question this study aims to answer is whether magnesium supplementation protocols targeting a higher or lower level lead to better 30-day survival and less atrial fibrillation. Participants will not have to do any specific tasks, undergo any additional tests, or complete any surveys.

This prospective, observational cohort study aims to evaluate whether the dynamic monitoring of a patient's breathing effort can predict successful liberation from invasive mechanical ventilation. The study will include 120 patients who have undergone 36 hours or more of controlled mechanical ventilation and deep sedation. Patient monitoring will commence immediately upon their transition to an assisted spontaneous breathing mode with pressure support. Starting from this clinical milestone, the researchers will track the patients' longitudinal inspiratory effort daily through four specific variables: maximum occlusion pressure, muscle pressure index, flow index via visual waveform inspection, and diaphragmatic thickening fraction via ultrasound. Concurrently, ventilator safety parameters (plateau pressure, driving pressure, transpulmonary pressure, and compliance) will be recorded. The primary outcome is the time from PSV initiation to successful weaning (defined as 72 hours without ventilator support). Clinical events such as death or return to a controlled mode due to PSV failure will be statistically treated as competing risks. Secondary outcomes include the incidence of pneumonia, ICU-acquired weakness, delirium, mortality, and PSV failure. Data will be analyzed using multivariate joint modeling within a Bayesian framework.

This prospective cohort study aims to assess the nutritional status of critically ill children aged 1 month to 5 years admitted to the pediatric intensive care unit using a comprehensive ABCD approach including anthropometric, biochemical, clinical, and dietary assessment within 48 hours of admission, and to evaluate its association with clinical outcomes including duration of mechanical ventilation, length of PICU stay, and mortality.

Central venous access is critical for administering intravenous medications, parenteral nutrition, and fluid therapy in intensive care units (ICUs). Peripherally inserted central catheters (PICCs) provide an alternative to traditional centrally placed catheters, but they can be associated with complications such as blood clots (thrombosis), catheter-related infections, and mechanical blockages. The primary purpose of this study is to assess the procedural efficacy, functional lifespan, and complication rates of ultrasound-guided PICCs in critically ill adult patients. In this prospective observational study, 60 adult ICU patients who require central venous access for at least 5 to 7 days will undergo bedside PICC placement by radiology staff using real-time ultrasound guidance and the modified Seldinger technique. Proper positioning of the catheter tip will be verified by a portable chest radiograph immediately after insertion. Participants will be monitored daily while the catheter remains in place until line removal, ICU discharge, or death. Surveillance includes daily clinical site inspections, structured laboratory assessments, and scheduled compression Doppler ultrasound scans to check for blood clots in the cannulated arm. If an infection or blockage is suspected, appropriate blood cultures and diagnostic work-ups will be conducted. The gathered data will determine the insertion success rate, functional patency rate, and the overall incidence of complications per 1,000 catheter-days to establish evidence-based guidelines for vascular access in critical care.