An observational study in Extubation, sponsored by University Health Network, Toronto. Recruiting at 35 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by University Health Network, Toronto · 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).
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.
Despite 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.
There 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.
EXTUBE (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
The primary objective of this study is to estimate the incidence of immediate complications related to extubation in adult patients after general anesthesia and/or 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.
University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
For each patient who is not included, reasons for exclusion will be reported.
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: i) Severe hypoxemia (oxygen saturation as measured by pulse oximetry falls below SpO2 \< 80% for \> 5 minutes) ii) Cardiac arrest iii) Need for airway management (reintubation, insertion of a supraglottic airway, bag-mask ventilation).
Time frame: Within 60 minutes after the end of extubation
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
Time frame: Within 60 minutes after the end of extubation
Planned and unplanned non-invasive respiratory support
Planned and unplanned non-invasive respiratory support or high flow nasal cannula
Time frame: Within 60 minutes after the end of extubation
Emergency front of neck airway
Emergency front of neck airway should airway management be required after extubation
Time frame: Within 60 minutes after the end of extubation
Cardiac arrhythmia requiring chemical or electrical treatment
Cardiac arrhythmia requiring chemical or electrical treatment
Time frame: Within 60 minutes after the end of extubation
Severe Hypotension
Severe hypotension (systolic arterial pressure \< 65 mmHg recorded at any time or systolic arterial pressure \< 90 mmHg for \> 30 minutes or new need/increase of vasopressor and/or fluid load \> 15 mL/kg)
Time frame: Within 60 minutes after the end of extubation
Severe Hypertension
Severe hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥120 mmHg),
Time frame: Within 60 minutes after the end of extubation
Pulmonary aspiration
Aspiration of gastric contents (gastric contents inhaled into the larynx and the respiratory tract)
Time frame: Within 60 minutes after the end of extubation
Barotrauma
Pneumothorax/pneumo-mediastinum
Time frame: Within 60 minutes after the end of extubation
Dental injury
Dental injury (notable change to the patient's dentition attributable to extubation or to reintubation, should this be required)
Time frame: Within 60 minutes after the end of extubation
Airways injury
Airways injury (e.g., vocal cord damage, arytenoid dislocation
Time frame: Within 60 minutes after the end of extubation
Mortality
In-hospital mortality
Time frame: Within 7 days after extubation
Re-intubation
Re-intubation within 48 hours of extubation
Time frame: Within 48 hours after extubation
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Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Dec 2027, 32 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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