[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650869":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":65,"collaborators":10,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":10,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":10,"enrollmentInfo":77,"targetDuration":80,"studyType":81,"phases":10,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Kocaeli City Hospital","OTHER_GOV",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"On-Hours",null,"On-hours group: Extubations performed between 08:00 and 16:00 on weekdays (Monday to Friday), excluding public holidays.",[13,14],"Procedure: Extubation","Other: Survey\u002FQuestionnaire Administration",{"label":16,"type":10,"description":17,"interventionNames":18},"Off-Hours","Off-hours group: Extubations performed after 16:00 on weekdays, as well as all extubations performed on weekends and public holidays, regardless of the time of day",[13,14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"PROCEDURE","Extubation","An extubation attempt is the planned, deliberate removal of the endotracheal tube from the patient's trachea, beginning with preparatory manoeuvres (such as oropharyngeal suctioning and cuff deflation) and ending with the complete withdrawal of the tube and establishment of a patent native airway with adequate spontaneous breathing.",[16,9],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"OTHER","Survey\u002FQuestionnaire Administration","Description: The Karolinska Sleepiness Scale (KSS), a validated 9-point Likert scale (1 = extremely alert, 9 = very sleepy, fighting sleep), will be administered to the attending anaesthetist responsible for performing the extubation immediately prior to the extubation procedure. This assessment is performed to objectively quantify the clinician's subjective level of sleepiness and fatigue at the time of extubation. The KSS score will be recorded as a predictor\u002Fexposure variable to evaluate the association between anaesthetist fatigue and the occurrence of acute airway and respiratory complications during extubation. This assessment is applied uniformly across both study groups (on-hours and off-hours extubations).",[16,9],[31],{"name":32,"affiliation":5,"role":33},"Mehmet Yilmaz","STUDY_CHAIR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"Ali Mete Temel, MD","CONTACT","+905438465215","metetemel60@hotmail.com",{"name":41,"role":37,"phone":42,"phoneExt":10,"email":43},"Mehmet Yilmaz, Md","05052174432","drmyilmaz33@gmail.com",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":10,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Kocaeli","Izmıt","41001","Turkey (Türkiye)",{"type":52,"coordinates":53},"Point",[54,55],27.51145,39.62497,{"lat":55,"lon":54},[58,60,61,63],{"name":59,"role":37,"phone":38,"phoneExt":10,"email":39},"Ali Mete Temel, Md",{"name":41,"role":37,"phone":42,"phoneExt":10,"email":43},{"name":59,"role":62,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":41,"role":64,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"type":62,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Ali Mete Temel","Anesthesiology and Reanimation Resident Physician","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":78,"type":79},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.",[84,22,85],"Extubation Failures","Airway Complication of Anaesthesia",[22,87,88,89,90],"Airway complications","Off-hours","General anaesthesia","Prospective cohort study","2026-08-15",{"date":93,"type":94},"2026-08-18","ACTUAL",{"date":96,"type":79},"2026-08-03",{"date":98,"type":79},"2027-05-15",{"name":5,"class":6},1]