[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550119":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":55,"studyPopulation":56,"armGroups":51,"interventions":51,"overallOfficials":57,"centralContacts":62,"locations":72,"responsibleParty":397,"collaborators":51,"id":399,"slug":400,"hasResults":401,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":401,"sex":407,"minAge":408,"maxAge":51,"enrollmentInfo":409,"targetDuration":51,"studyType":412,"phases":51,"briefSummary":413,"conditions":414,"keywords":51,"overallStatus":238,"whyStopped":51,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":425},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":51},[9],{"measure":10,"description":11,"timeFrame":12},"At least one of the following, occurring within 60minutes after extubation (composite outcome): i) Severe hypoxemia ii) Cardiac arrest iii) Need for airway management","The primary outcome will be the occurrence of at least one of the following (composite outcome) occurring within 60 minutes after the end of extubation:\n\ni) Severe hypoxemia (oxygen saturation as measured by pulse oximetry falls below SpO2 \\\u003C 80% for \\> 5 minutes) ii) Cardiac arrest iii) Need for airway management (reintubation, insertion of a supraglottic airway, bag-mask ventilation).","Within 60 minutes after the end of extubation",[14,17,20,23,25,28,31,34,37,40,43,47],{"measure":15,"description":16,"timeFrame":12},"Difficult airway and complications related to airway management if reintubation is required","Difficult airway (i.e., experienced difficulty by an experienced airway manager with any or all of laryngoscopy or tracheal intubation, supraglottic airway use, face-mask ventilation, or front-of-neck airway) and complications related to airway management (e.g., esophageal intubation) if reintubation is required",{"measure":18,"description":19,"timeFrame":12},"Planned and unplanned non-invasive respiratory support","Planned and unplanned non-invasive respiratory support or high flow nasal cannula",{"measure":21,"description":22,"timeFrame":12},"Emergency front of neck airway","Emergency front of neck airway should airway management be required after extubation",{"measure":24,"description":24,"timeFrame":12},"Cardiac arrhythmia requiring chemical or electrical treatment",{"measure":26,"description":27,"timeFrame":12},"Severe Hypotension","Severe hypotension (systolic arterial pressure \\\u003C 65 mmHg recorded at any time or systolic arterial pressure \\\u003C 90 mmHg for \\> 30 minutes or new need\u002Fincrease of vasopressor and\u002For fluid load \\> 15 mL\u002Fkg)",{"measure":29,"description":30,"timeFrame":12},"Severe Hypertension","Severe hypertension (systolic blood pressure ≥180 mmHg and\u002For diastolic blood pressure ≥120 mmHg),",{"measure":32,"description":33,"timeFrame":12},"Pulmonary aspiration","Aspiration of gastric contents (gastric contents inhaled into the larynx and the respiratory tract)",{"measure":35,"description":36,"timeFrame":12},"Barotrauma","Pneumothorax\u002Fpneumo-mediastinum",{"measure":38,"description":39,"timeFrame":12},"Dental injury","Dental injury (notable change to the patient's dentition attributable to extubation or to reintubation, should this be required)",{"measure":41,"description":42,"timeFrame":12},"Airways injury","Airways injury (e.g., vocal cord damage, arytenoid dislocation",{"measure":44,"description":45,"timeFrame":46},"Mortality","In-hospital mortality","Within 7 days after extubation",{"measure":48,"description":49,"timeFrame":50},"Re-intubation","Re-intubation within 48 hours of extubation","Within 48 hours after extubation",null,{"allocation":51,"interventionModel":51,"interventionModelDescription":51,"primaryPurpose":51,"observationalModel":53,"timePerspective":54,"maskingInfo":51},"COHORT","PROSPECTIVE","Globally, over 200 million people each year require extubation. While routinely performed, extubation is a skilled and potentially high-risk procedure that should be performed only when physiologic, pharmacologic, and contextual conditions are optimal. Complications at this stage of patient care can result in decreased oxygen delivery to the brain and body, sometimes leading to serious adverse events such as cardiac arrest, brain damage, or death. Indeed, one quarter of airway complications that result in death or brain death occur at the time of extubation.\n\nDespite the frequency of extubation and the potential for life-threatening complications, there is a lack of systematic data on the rate and circumstances under which these severe complications occur. The limited data indicate 10-30% of extubations may lead to severe complications, depending on the population and outcome definition. However, the certainty of these estimates is severely limited because they are based on studies that are small, mostly single-center, based on clinician recall, only capture a small portion of extubation complications (e.g., malpractice claims), or do not reflect current clinical practice. In addition, most lack a denominator and exclude successful extubations, making estimates of actual complication rates and risk factors impossible.\n\nThere has been no large study of extubation techniques or adherence to guidelines, so procedural factors associated with complications must be elucidated. While adherence to clinical practice guidelines has not been formally evaluated, surveys show non-adherence to some best practices and considerable variation in practice, and data from audits and medicolegal claims show that lack of adherence to best practices is frequently at the root cause of severe adverse extubation outcomes, with half of the complications deemed preventable. Therefore, data on the frequency and nature of extubation complications, patient and procedural risk factors for complications, and guideline adherence rates are needed before these preventable events can be addressed.\n\nEXTUBE (EXtubation related complications - an international observational study To Understand the impact and BEst practices in the operating room and intensive care unit) is an international, multicenter, prospective cohort study\n\nThe primary objective of this study is to estimate the incidence of immediate complications related to extubation in adult patients after general anesthesia and\u002For after critical illness. The secondary objectives are to determine: 1) the incidence of mild extubation complications; 2) patient- and procedure-related risk factors for extubation complications; 3) the association between extubation complications and outcomes until hospital discharge; and 4) the rate of adherence to extubation clinical practice guidelines.","All adult patients (≥18 years old) undergoing extubation of an endotracheal tube (including index extubation and re-extubations) after general anesthesia in the OR, out of OR anesthesia location or ICU during the specified enrollment window (up to 4 weeks).",[58],{"name":59,"affiliation":60,"role":61},"Matteo Parotto, MD, PhD","UHN","PRINCIPAL_INVESTIGATOR",[63,67],{"name":59,"role":64,"phone":65,"phoneExt":51,"email":66},"CONTACT","+1 416 340 3567","matteo.parotto@uhn.ca",{"name":68,"role":64,"phone":69,"phoneExt":70,"email":71},"Shayan Wasim, MPH, BSc","+1 416 340 4800","4221","shayan.wasim@uhn.ca",[73,87,97,107,117,127,137,149,159,166,172,178,184,190,202,212,217,221,230,236,252,258,268,278,289,298,307,316,337,347,358,367,377,388],{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":51},"Banner University Medical Centre","COMPLETED","Tucson","Arizona","85724-5114","United States","US",{"type":82,"coordinates":83},"Point",[84,85],-110.92648,32.22174,{"lat":85,"lon":84},{"facility":88,"status":75,"city":89,"state":90,"zip":91,"country":79,"countryCode":80,"cosmosGeoPoint":92,"geoPoint":96,"contacts":51},"University of Arkansas for Medical Sciences","Little Rock","Arkansas","72205",{"type":82,"coordinates":93},[94,95],-92.28959,34.74648,{"lat":95,"lon":94},{"facility":98,"status":75,"city":99,"state":100,"zip":101,"country":79,"countryCode":80,"cosmosGeoPoint":102,"geoPoint":106,"contacts":51},"University of Florida","Gainesville","Florida","32608",{"type":82,"coordinates":103},[104,105],-82.32483,29.65163,{"lat":105,"lon":104},{"facility":108,"status":75,"city":109,"state":110,"zip":111,"country":79,"countryCode":80,"cosmosGeoPoint":112,"geoPoint":116,"contacts":51},"The University of Chicago","Chicago","Illinois","60637",{"type":82,"coordinates":113},[114,115],-87.65005,41.85003,{"lat":115,"lon":114},{"facility":118,"status":75,"city":119,"state":120,"zip":121,"country":79,"countryCode":80,"cosmosGeoPoint":122,"geoPoint":126,"contacts":51},"Oregon Health & Science University","Portland","Oregon","97239",{"type":82,"coordinates":123},[124,125],-122.67621,45.52345,{"lat":125,"lon":124},{"facility":128,"status":75,"city":129,"state":130,"zip":131,"country":79,"countryCode":80,"cosmosGeoPoint":132,"geoPoint":136,"contacts":51},"The University of Texas Health Science Center","Houston","Texas","77030",{"type":82,"coordinates":133},[134,135],-95.36327,29.76328,{"lat":135,"lon":134},{"facility":138,"status":75,"city":139,"state":140,"zip":141,"country":142,"countryCode":143,"cosmosGeoPoint":144,"geoPoint":148,"contacts":51},"Royal North Shore Hospital","Sydney","New South Wales","2065","Australia","AU",{"type":82,"coordinates":145},[146,147],151.20732,-33.86785,{"lat":147,"lon":146},{"facility":150,"status":75,"city":151,"state":152,"zip":153,"country":142,"countryCode":143,"cosmosGeoPoint":154,"geoPoint":158,"contacts":51},"The Northern Hospital","Melbourne","Victoria","3076",{"type":82,"coordinates":155},[156,157],144.96332,-37.814,{"lat":157,"lon":156},{"facility":160,"status":161,"city":151,"state":152,"zip":162,"country":142,"countryCode":143,"cosmosGeoPoint":163,"geoPoint":165,"contacts":51},"Austin Health - Heidelberg Repatriation Hospital","ACTIVE_NOT_RECRUITING","3079",{"type":82,"coordinates":164},[156,157],{"lat":157,"lon":156},{"facility":167,"status":75,"city":151,"state":152,"zip":168,"country":142,"countryCode":143,"cosmosGeoPoint":169,"geoPoint":171,"contacts":51},"Austin Health - Austin Hospital","3084",{"type":82,"coordinates":170},[156,157],{"lat":157,"lon":156},{"facility":173,"status":75,"city":151,"state":152,"zip":174,"country":142,"countryCode":143,"cosmosGeoPoint":175,"geoPoint":177,"contacts":51},"Eastern Health - Box Hill Hospital","3128",{"type":82,"coordinates":176},[156,157],{"lat":157,"lon":156},{"facility":179,"status":75,"city":151,"state":152,"zip":180,"country":142,"countryCode":143,"cosmosGeoPoint":181,"geoPoint":183,"contacts":51},"Eastern Health - Maroondah Hospital","3135",{"type":82,"coordinates":182},[156,157],{"lat":157,"lon":156},{"facility":185,"status":75,"city":151,"state":152,"zip":186,"country":142,"countryCode":143,"cosmosGeoPoint":187,"geoPoint":189,"contacts":51},"Eastern Health - Angliss Hospital","3156",{"type":82,"coordinates":188},[156,157],{"lat":157,"lon":156},{"facility":191,"status":75,"city":192,"state":193,"zip":194,"country":195,"countryCode":196,"cosmosGeoPoint":197,"geoPoint":201,"contacts":51},"Surrey Memorial Hospital","Surrey","British Columbia","V3V 1Z2","Canada","CA",{"type":82,"coordinates":198},[199,200],-122.82509,49.10635,{"lat":200,"lon":199},{"facility":203,"status":75,"city":204,"state":205,"zip":206,"country":195,"countryCode":196,"cosmosGeoPoint":207,"geoPoint":211,"contacts":51},"The Moncton Hospital","Moncton","New Brunswick","E1C 4B7",{"type":82,"coordinates":208},[209,210],-64.7965,46.09454,{"lat":210,"lon":209},{"facility":213,"status":75,"city":214,"state":215,"zip":216,"country":195,"countryCode":196,"cosmosGeoPoint":51,"geoPoint":51,"contacts":51},"Sunnybrook Hospital","North York","Ontario","M4N 3M5",{"facility":218,"status":75,"city":219,"state":215,"zip":220,"country":195,"countryCode":196,"cosmosGeoPoint":51,"geoPoint":51,"contacts":51},"Niagara Health - Marotta Family Hospital","Saint Catharines","L2S 0A9",{"facility":222,"status":75,"city":223,"state":215,"zip":224,"country":195,"countryCode":196,"cosmosGeoPoint":225,"geoPoint":229,"contacts":51},"St. Michael's Hospital","Toronto","M5B 1W8",{"type":82,"coordinates":226},[227,228],-79.39864,43.70643,{"lat":228,"lon":227},{"facility":231,"status":75,"city":223,"state":215,"zip":232,"country":195,"countryCode":196,"cosmosGeoPoint":233,"geoPoint":235,"contacts":51},"Mount Sinai Hospital","M5G 1X5",{"type":82,"coordinates":234},[227,228],{"lat":228,"lon":227},{"facility":237,"status":238,"city":223,"state":215,"zip":239,"country":195,"countryCode":196,"cosmosGeoPoint":240,"geoPoint":242,"contacts":243},"University Health Network - Toronto General Hospital","RECRUITING","M5G 2C4",{"type":82,"coordinates":241},[227,228],{"lat":228,"lon":227},[244,246,248,249],{"name":59,"role":64,"phone":245,"phoneExt":51,"email":66},"416-340-3567",{"name":68,"role":64,"phone":247,"phoneExt":70,"email":71},"416-340-4800",{"name":59,"role":61,"phone":51,"phoneExt":51,"email":51},{"name":250,"role":251,"phone":51,"phoneExt":51,"email":51},"Alicia Grassi, MD","SUB_INVESTIGATOR",{"facility":253,"status":75,"city":223,"state":215,"zip":254,"country":195,"countryCode":196,"cosmosGeoPoint":255,"geoPoint":257,"contacts":51},"University Health Network - Toronto Western Hospital","M5T 2S8",{"type":82,"coordinates":256},[227,228],{"lat":228,"lon":227},{"facility":259,"status":75,"city":260,"state":261,"zip":262,"country":195,"countryCode":196,"cosmosGeoPoint":263,"geoPoint":267,"contacts":51},"Centre hospitalier de l'Université de Montréal (CHUM)","Montreal","Quebec","H2X 0C1",{"type":82,"coordinates":264},[265,266],-73.58781,45.50884,{"lat":266,"lon":265},{"facility":269,"status":75,"city":270,"state":51,"zip":51,"country":271,"countryCode":272,"cosmosGeoPoint":273,"geoPoint":277,"contacts":51},"Hospital Internacional de Colombia","Piedecuesta","Colombia","CO",{"type":82,"coordinates":274},[275,276],-73.04953,6.98789,{"lat":276,"lon":275},{"facility":279,"status":75,"city":280,"state":51,"zip":281,"country":282,"countryCode":283,"cosmosGeoPoint":284,"geoPoint":288,"contacts":51},"Mayo University Hospital","Castlebar","F23 H529","Ireland","IE",{"type":82,"coordinates":285},[286,287],-9.3,53.85,{"lat":287,"lon":286},{"facility":290,"status":75,"city":291,"state":51,"zip":292,"country":282,"countryCode":283,"cosmosGeoPoint":293,"geoPoint":297,"contacts":51},"Cork University Hospital","Cork","T12 DFK4",{"type":82,"coordinates":294},[295,296],-8.47061,51.89797,{"lat":296,"lon":295},{"facility":299,"status":75,"city":300,"state":51,"zip":301,"country":282,"countryCode":283,"cosmosGeoPoint":302,"geoPoint":306,"contacts":51},"Mater Misericordiae University Hospital","Dublin","D07 R2WY",{"type":82,"coordinates":303},[304,305],-6.24889,53.33306,{"lat":305,"lon":304},{"facility":308,"status":75,"city":309,"state":51,"zip":310,"country":282,"countryCode":283,"cosmosGeoPoint":311,"geoPoint":315,"contacts":51},"Galway University Hospitals","Galway","H91 YR71",{"type":82,"coordinates":312},[313,314],-9.05095,53.27245,{"lat":314,"lon":313},{"facility":317,"status":318,"city":319,"state":51,"zip":320,"country":282,"countryCode":283,"cosmosGeoPoint":321,"geoPoint":325,"contacts":326},"University Hospital Waterford","NOT_YET_RECRUITING","Waterford","X91 ER8E",{"type":82,"coordinates":322},[323,324],-7.11194,52.25833,{"lat":324,"lon":323},[327,331,334,335],{"name":328,"role":64,"phone":329,"phoneExt":51,"email":330},"Dulmi T Nawarathna, MBBS, MCAI, FCAI","(+353) 0518482425","dulmi.nawarathna@hse.ie",{"name":332,"role":64,"phone":51,"phoneExt":51,"email":333},"Erin Crowley, PhD, MPharm","erin.crowley@ucc.ie",{"name":328,"role":61,"phone":51,"phoneExt":51,"email":51},{"name":336,"role":251,"phone":51,"phoneExt":51,"email":51},"Sheeba Hakak, MBBS, FCARCSI, EDIC, HCM.",{"facility":338,"status":161,"city":339,"state":51,"zip":51,"country":340,"countryCode":341,"cosmosGeoPoint":342,"geoPoint":346,"contacts":51},"Amiri Hospital","Kuwait City","Kuwait","KW",{"type":82,"coordinates":343},[344,345],47.97429,29.367,{"lat":345,"lon":344},{"facility":348,"status":75,"city":349,"state":51,"zip":350,"country":351,"countryCode":352,"cosmosGeoPoint":353,"geoPoint":357,"contacts":51},"Southland Hospital","Invercargill","9812","New Zealand","NZ",{"type":82,"coordinates":354},[355,356],168.35,-46.4,{"lat":356,"lon":355},{"facility":359,"status":75,"city":360,"state":51,"zip":361,"country":351,"countryCode":352,"cosmosGeoPoint":362,"geoPoint":366,"contacts":51},"Rotorua Hospital","Rotorua","3010",{"type":82,"coordinates":363},[364,365],176.24516,-38.13874,{"lat":365,"lon":364},{"facility":368,"status":75,"city":369,"state":51,"zip":370,"country":369,"countryCode":371,"cosmosGeoPoint":372,"geoPoint":376,"contacts":51},"Tan Tock Seng Hospital","Singapore","308433","SG",{"type":82,"coordinates":373},[374,375],103.85007,1.28967,{"lat":375,"lon":374},{"facility":378,"status":75,"city":379,"state":51,"zip":380,"country":381,"countryCode":382,"cosmosGeoPoint":383,"geoPoint":387,"contacts":51},"Royal United Hospitals Bath","Bath","BA1 3NG","United Kingdom","UK",{"type":82,"coordinates":384},[385,386],-2.36172,51.3751,{"lat":386,"lon":385},{"facility":389,"status":75,"city":390,"state":51,"zip":391,"country":381,"countryCode":382,"cosmosGeoPoint":392,"geoPoint":396,"contacts":51},"Freeman Hospital","Newcastle upon Tyne","NE7 7DN",{"type":82,"coordinates":393},[394,395],-1.61396,54.97328,{"lat":395,"lon":394},{"type":398,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR","100550119","extubation-related-complications---the-extube-study-extube-100550119",false,"NCT06442930","EXtubation Related Complications - the EXTUBE Study (EXTUBE)","EXtubation Related Complications - an International Observational Study To Understand the Impact and BEst Practices in the Operating Room and Intensive Care Unit - the EXTUBE Study","EXTUBE","Inclusion Criteria:\n\n* Adult patients (≥18 years old)\n* Undergoing extubation of an endotracheal tube (including index extubation and re-extubations) after general anesthesia in the OR, out of OR anesthesia location or ICU\n* Undergoing extubation during the specified enrollment window\n\nExclusion Criteria:\n\n* Patients will be excluded if the extubation is performed in the context of withdrawal of life support measures,\n* Patients will be excluded if the extubation is performed for tracheostomy decannulation\n\nFor each patient who is not included, reasons for exclusion will be reported.","ALL","18 Years",{"count":410,"type":411},3000,"ESTIMATED","OBSERVATIONAL","EXTUBE is an international, multicentre, prospective cohort study evaluating the incidence, risk factors, and outcomes of extubation-related complications and describing clinical practices related to extubation after general anesthesia or after critical illness in the operating room (OR), out of OR anesthesia location or intensive care unit (ICU).",[415],"Extubation","2026-08-14",{"date":418,"type":419},"2026-08-17","ACTUAL",{"date":421,"type":419},"2025-04-14",{"date":423,"type":411},"2027-12",{"name":5,"class":6},34]