ExtubationEXTUBENCT06442930
EXtubation Related Complications - the EXTUBE Study (EXTUBE)
An observational study of Extubation, run by University Health Network, Toronto at 35 sites in 9 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extubation
- How many people
- 3,000 participants
- Where
- 35 sitesin 9 countries
- Study dates
- 14 Apr 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- 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
- Undergoing extubation during the specified enrollment window
Who cannot join
- Patients will be excluded if the extubation is performed in the context of withdrawal of life support measures,
- Patients will be excluded if the extubation is performed for tracheostomy decannulation
- For each patient who is not included, reasons for exclusion will be reported.
Trial locations and contacts
35 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
35 sites in 9 countries
Canada9 sites, 1 recruiting
- Completed
The Moncton Hospital
Moncton, New Brunswick, E1C 4B7
- Completed
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0C1
- Completed
Sunnybrook Hospital
North York, Ontario, M4N 3M5
- Completed
Niagara Health - Marotta Family Hospital
Saint Catharines, Ontario, L2S 0A9
- Completed
Surrey Memorial Hospital
Surrey, British Columbia, V3V 1Z2
- Completed
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
- Completed
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
- Recruiting
University Health Network - Toronto General Hospital
Toronto, Ontario, M5G 2C4
Matteo Parotto, MD, PhD, 416-340-3567, matteo.parotto@uhn.ca
Shayan Wasim, MPH, BSc, 416-340-4800 ext. 4221, shayan.wasim@uhn.ca
- Completed
University Health Network - Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Australia7 sites
- Completed
The Northern Hospital
Melbourne, Victoria, 3076
- Completed
Austin Health - Heidelberg Repatriation Hospital
Melbourne, Victoria, 3079
- Completed
Austin Health - Austin Hospital
Melbourne, Victoria, 3084
- Completed
Eastern Health - Box Hill Hospital
Melbourne, Victoria, 3128
- Completed
Eastern Health - Maroondah Hospital
Melbourne, Victoria, 3135
- Completed
Eastern Health - Angliss Hospital
Melbourne, Victoria, 3156
- Completed
Royal North Shore Hospital
Sydney, New South Wales, 2065
United States6 sites
- Completed
The University of Chicago
Chicago, Illinois, 60637
- Completed
University of Florida
Gainesville, Florida, 32608
- Completed
The University of Texas Health Science Center
Houston, Texas, 77030
- Completed
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
- Completed
Oregon Health & Science University
Portland, Oregon, 97239
- Completed
Banner University Medical Centre
Tucson, Arizona, 85724-5114
Ireland5 sites, 1 recruiting
- Completed
Mayo University Hospital
Castlebar, F23 H529
- Completed
Cork University Hospital
Cork, T12 DFK4
- Completed
Mater Misericordiae University Hospital
Dublin, D07 R2WY
- Completed
Galway University Hospitals
Galway, H91 YR71
- Not yet recruiting
University Hospital Waterford
Waterford, X91 ER8E
Dulmi T Nawarathna, MBBS, MCAI, FCAI, (+353) 0518482425, dulmi.nawarathna@hse.ie
Erin Crowley, PhD, MPharm, erin.crowley@ucc.ie
New Zealand3 sites
- Completed
Auckland City Hospital
Auckland, 1023
- Completed
Southland Hospital
Invercargill, 9812
- Completed
Rotorua Hospital
Rotorua, 3010
United Kingdom2 sites
- Completed
Royal United Hospitals Bath
Bath, BA1 3NG
- Completed
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
About this study
Official title: 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 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).
Read the detailed description
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.
- Conditions
- Extubation
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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).
Measured: Within 60 minutes after the end of extubation
Secondary outcomes (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
Measured: 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
Measured: 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
Measured: Within 60 minutes after the end of extubation
Cardiac arrhythmia requiring chemical or electrical treatment
Cardiac arrhythmia requiring chemical or electrical treatment
Measured: 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)
Measured: Within 60 minutes after the end of extubation
Severe Hypertension
Severe hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥120 mmHg),
Measured: Within 60 minutes after the end of extubation
Pulmonary aspiration
Aspiration of gastric contents (gastric contents inhaled into the larynx and the respiratory tract)
Measured: Within 60 minutes after the end of extubation
Barotrauma
Pneumothorax/pneumo-mediastinum
Measured: 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)
Measured: Within 60 minutes after the end of extubation
Airways injury
Airways injury (e.g., vocal cord damage, arytenoid dislocation
Measured: Within 60 minutes after the end of extubation
Mortality
In-hospital mortality
Measured: Within 7 days after extubation
Re-intubation
Re-intubation within 48 hours of extubation
Measured: Within 48 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start14 Apr 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExtubationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Parotto, MD, PhD, Principal investigator, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442930
- Sponsor's protocol ID
- 24-5811
- Other IDs
- 4850
- Acronym
- EXTUBE
- Status last verified
- Aug 2026
- First submitted
- 28 Mar 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06442930
- Acronym / sponsor ID
- EXTUBE / 24-5811
- Conditions
- Extubation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (3 listed)
- 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
- Undergoing extubation during the specified enrollment window
Key exclusion criteria (3 listed)
- Patients will be excluded if the extubation is performed in the context of withdrawal of life support measures,
- Patients will be excluded if the extubation is performed for tracheostomy decannulation
- For each patient who is not included, reasons for exclusion will be reported.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
At least one of the following, occurring within 60minutes after extubation (composite outcome): i) Severe hypoxemia ii) Cardiac arrest iii) Need for airway management
Time frame: Within 60 minutes after the end of extubation
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).
12 secondary outcomes
Difficult airway and complications related to airway management if reintubation is required
Time frame: Within 60 minutes after the end of extubation
Planned and unplanned non-invasive respiratory support
Time frame: Within 60 minutes after the end of extubation
Emergency front of neck airway
Time frame: Within 60 minutes after the end of extubation
Cardiac arrhythmia requiring chemical or electrical treatment
Time frame: Within 60 minutes after the end of extubation
Severe Hypotension
Time frame: Within 60 minutes after the end of extubation
Severe Hypertension
Time frame: Within 60 minutes after the end of extubation
Pulmonary aspiration
Time frame: Within 60 minutes after the end of extubation
Barotrauma
Time frame: Within 60 minutes after the end of extubation
Dental injury
Time frame: Within 60 minutes after the end of extubation
Airways injury
Time frame: Within 60 minutes after the end of extubation
Mortality
Time frame: Within 7 days after extubation
Re-intubation
Time frame: Within 48 hours after extubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Extubation
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Extubation Success, Extubation Failure
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RecruitingPhase 4
Remifentanil Versus Remifentanil-Lidocaine for Tracheal Extubation After Thyroidectomy
Tracheal Extubation, Cough
Enrolling by invitationObservational study
Difficult Airway Management in Oncology: An International Delphi Consensus Study (DAMO)
Neoplasms, Airway Obstruction Upper
RecruitingObservational study
Comparison of Acute Airway/Respiratory Complications and Intervention Requirements in Extubations Performed During On-Hours Versus Off-Hours
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matteo Parotto, MD, PhD principal investigator
UHN
35 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extubation, run by University Health Network, Toronto at 35 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Canada, Australia, United States, Ireland, New Zealand and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matteo Parotto, MD, PhD (+1 416 340 3567, matteo.parotto@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
At least one of the following, occurring within 60minutes after extubation (composite outcome): i) Severe hypoxemia ii) Cardiac arrest iii) Need for airway management (time frame: Within 60 minutes after the end of extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.