[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"extubation-failures\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:extubation-failures":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100650869","comparison-of-acute-airwayrespiratory-complications-and-intervention-requirements-in-extubations-performed-during-on-hours-versus-off-hours-a-prospective-observational-cohort-study-100650869",false,"NCT07752173","Comparison of Acute Airway\u002FRespiratory Complications and Intervention Requirements in Extubations Performed During On-Hours Versus Off-Hours","Comparison of Acute Airway\u002FRespiratory Complications and Intervention Requirements in Extubations Performed During On-Hours Versus Off-Hours: A Prospective Observational Cohort Study","Inclusion Criteria:\n\n\\- Age ≥ 18 years\n\nUndergoing elective or emergency surgery under general anaesthesia with endotracheal intubation\n\nPlanned tracheal extubation in the operating theatre or post-anaesthesia care unit (PACU)\n\nProvision of written informed consent (or deferred consent for emergency cases, in accordance with national regulations)\n\nExclusion Criteria:\n\n* Patients undergoing surgery under regional anaesthesia or sedation without endotracheal intubation\n\nPatients with a tracheostomy in situ\n\nPatients who remain intubated and are transferred to the intensive care unit (ICU) postoperatively\n\nPatients undergoing cardiothoracic surgery involving cardiopulmonary bypass\n\nEmergency airway management performed outside the operating theatre (e.g., ICU, emergency department)\n\nPatients with known or suspected difficult airway requiring awake fibreoptic intubation\n\nPatients who refuse to provide informed consent or withdraw consent during the study\n\nPregnant patients","ALL","18 Years",{"count":19,"type":20},2640,"ESTIMATED","1 Day","OBSERVATIONAL","Perioperative airway\u002Frespiratory complications are a major driver of morbidity and mortality. While UK audits NAP4 and NAP7 extensively examined major critical events (e.g., cardiac arrest), prospective standardized data on acute, more frequent extubation-phase complications-such as desaturation, laryngospasm, obstruction, bronchospasm, and aspiration-remain scarce. Off-hours procedures carry additional risks related to increased workload, reduced senior supervision, and clinician fatigue, though current evidence is inconclusive and requires further human-factors research using validated tools like the Karolinska Sleepiness Scale (KSS). This prospective cohort study at Kocaeli City Hospital aims to compare the incidence of acute airway\u002Frespiratory complications and intervention requirements during extubation and the first 30 minutes post-extubation between on-hours (08:00-16:00) and off-hours (\\>16:00). Notably, this will be the first prospective observational study to specifically test NAP7's off-hours risk findings at the extubation stage, with the goal of strengthening patient safety and guiding institutional quality improvement.",[25,26,27],"Extubation Failures","Extubation","Airway Complication of Anaesthesia",[26,29,30,31,32],"Airway complications","Off-hours","General anaesthesia","Prospective cohort study","RECRUITING","2026-08-15",{"date":36,"type":37},"2026-08-18","ACTUAL",{"date":39,"type":20},"2026-08-03",{"date":41,"type":20},"2027-05-15",{"name":43,"class":44},"Kocaeli City Hospital","OTHER_GOV",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":17,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":45},"100561678","trial-of-spontaneous-breathing-test-100561678","NCT06593288","Trial of Spontaneous Breathing Test","Randomized Clinical Trial of Spontaneous Breathing Test","Inclusion Criteria:\n\n* Patients admitted to the PICU on MV for more than 24 hours\n* Patients over 1 month old (corrected gestational age \\> 38 weeks) and \\< 18 years old on the day of screening for ERT\n\nExclusion Criteria:\n\n* Perinatal-related lung disease\n* Congenital diaphragmatic hernia or congenital\u002Facquired paralysis of the diaphragm\n* Children with heart disease\n* Primary pulmonary hypertension\n* Bronchiolitis obliterans\n* Post-hematopoietic stem cell transplant; specifically, patients receiving continuous supplemental oxygen for three or more days prior to intubation; receiving noninvasive ventilation for more than 24 hours prior to intubation; receiving more than one vasoactive medication at the time of meeting the inclusion criteria; spending more than four days in the PICU prior to intubation; supported by or with immediate plans for renal replacement therapy; with two or more allogeneic transplants; who relapsed after transplant; or with diffuse alveolar hemorrhage\n* Post-lung transplantation\n* Home ventilator dependence with baseline Oxygen Saturation Index (OSI) \\>6 (baseline is defined as a stable period prior to the present illness)\n* Neuromuscular respiratory failure\n* Critical airway obstruction (e.g., post-laryngotracheal surgery or new tracheostomy) or anatomical lower airway obstruction (e.g., mediastinal mass)\n* Facial surgery or trauma in the past two weeks\n* Intracranial bleeding\n* Morbid obesity (2w-24mo: WHO weight-for-length z-score\u002Fheight z-score ≥+3; ≥2y: WHO body mass index (BMI)-for-age z-score ≥+3)\n* Family\u002Fmedical team unsupportive total (patient treatment considered futile)\n* Previously enrolled in a current study\n* Enrolled in any other clinical trial with intervention not approved for concomitant enrollment\n* Pregnancy","1 Month",{"count":55,"type":20},170,"INTERVENTIONAL",[58],"NA","The hypothesis is that the Spontaneous Breathing Test (SBT) without pressure support (PS) is not inferior to the SBT with pressure support in relation to the following outcomes: a) extubation failure; b) time on MV.\n\nThe main objective of this study is to determine whether SBT without PS is non-inferior to SBT with PS in relation to the primary outcome: a) extubation failure; and secondary outcomes: b) length of stay in the PICU and c) days free of MV.\n\nPacients will be randomized to 2 arms:\n\n1. SBT with PS\n2. SBT without PS (with PEEP only)",[61,62,63,25,64],"Mechanical Ventilation","Spontaneous Breathing Trial","Extubation Readiness","Pediatrics",[66,67,68,69],"spontaneous breathing trial","extubation readiness test","mechanical ventilation","pediatric intensive care","NOT_YET_RECRUITING","2024-12-03",{"date":73,"type":37},"2024-12-06",{"date":75,"type":20},"2025-03-10",{"date":77,"type":20},"2026-04",{"name":79,"class":80},"University of Sao Paulo","OTHER"]