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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Matteo Parotto, MD, PhD contact

+1 416 340 3567

matteo.parotto@uhn.ca

Shayan Wasim, MPH, BSc contact

+1 416 340 4800 ext. 4221

shayan.wasim@uhn.ca

35 sites in 9 countries

Canada9 sites, 1 recruiting
  • 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

    Completed
  • 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

    Recruiting
  • University Health Network - Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

    Completed

Other trials in Canada

Australia7 sites
  • 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

    Completed

Other trials in Australia

United States6 sites
  • 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

    Completed

Other trials in United States

Ireland5 sites, 1 recruiting
  • 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

    Completed
  • 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

    Not yet recruiting

Other trials in Ireland

New Zealand3 sites
  • Auckland City Hospital

    Auckland, 1023

    Completed
  • Southland Hospital

    Invercargill, 9812

    Completed
  • Rotorua Hospital

    Rotorua, 3010

    Completed

Other trials in New Zealand

United Kingdom2 sites
  • Royal United Hospitals Bath

    Bath, BA1 3NG

    Completed
  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

    Completed

Other trials in United Kingdom

Colombia1 site
  • Hospital Internacional de Colombia

    Piedecuesta

    Completed

Other trials in Colombia

Kuwait1 site
  • Amiri Hospital

    Kuwait City

    Completed

Other trials in Kuwait

Singapore1 site
  • Tan Tock Seng Hospital

    Singapore, 308433

    Completed

Other trials in Singapore

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.

  1. 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:

    1. 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)
  1. 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

  2. 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

  3. 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

  4. Cardiac arrhythmia requiring chemical or electrical treatment

    Cardiac arrhythmia requiring chemical or electrical treatment

    Measured: Within 60 minutes after the end of extubation

  5. 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

  6. 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

  7. 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

  8. Barotrauma

    Pneumothorax/pneumo-mediastinum

    Measured: Within 60 minutes after the end of extubation

  9. 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

  10. Airways injury

    Airways injury (e.g., vocal cord damage, arytenoid dislocation

    Measured: Within 60 minutes after the end of extubation

  11. Mortality

    In-hospital mortality

    Measured: Within 7 days after extubation

  12. 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.

  1. First posted5 Jun 2024
  2. Study start14 Apr 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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)
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

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.

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