EXtubation Related Complications - the EXTUBE Study (EXTUBE)

NCT06442930 | Recruiting

• 2 other identifiers: 24-58114850
• Study Type: observational
• Target: 3,000
• Locations: 8 countries
• Sites: 32

Brief 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 or intensive care unit (ICU).

Conditions

Extubation

Outcome Measures

Primary Outcomes (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: 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).

  Within 60 minutes after the end of extubation

Secondary Outcomes (12)

• Difficult airway and complications related to airway management if reintubation is required

  Within 60 minutes after the end of extubation

• Planned and unplanned non-invasive respiratory support

  Within 60 minutes after the end of extubation

• Emergency front of neck airway

  Within 60 minutes after the end of extubation

• Cardiac arrhythmia requiring chemical or electrical treatment

  Within 60 minutes after the end of extubation

• Severe Hypotension

  Within 60 minutes after the end of extubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (32)

Banner University Medical Centre

Tucson, Arizona, 85724-5114, United States

COMPLETED

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

COMPLETED

University of Florida

Gainesville, Florida, 32608, United States

COMPLETED

The University of Chicago

Chicago, Illinois, 60637, United States

COMPLETED

Oregon Health & Science University

Portland, Oregon, 97239, United States

COMPLETED

The University of Texas Health Science Center

Houston, Texas, 77030, United States

COMPLETED

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

COMPLETED

The Northern Hospital

Melbourne, Victoria, 3076, Australia

COMPLETED

Austin Hospital

Melbourne, Victoria, 3084, Australia

COMPLETED

Eastern Health - Box Hill Hospital

Melbourne, Victoria, 3128, Australia

COMPLETED

Eastern Health - Maroondah Hospital

Melbourne, Victoria, 3135, Australia

COMPLETED

Eastern Health - Angliss Hospital

Melbourne, Victoria, 3156, Australia

COMPLETED

Surrey Memorial Hospital

Surrey, British Columbia, V3V 1Z2, Canada

COMPLETED

The Moncton Hospital

Moncton, New Brunswick, E1C 4B7, Canada

COMPLETED

Sunnybrook Hospital

North York, Ontario, M4N 3M5, Canada

COMPLETED

Niagara Health - Marotta Family Hospital

Saint Catharines, Ontario, L2S 0A9, Canada

COMPLETED

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

COMPLETED

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

COMPLETED

University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

COMPLETED

University Health Network - Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

COMPLETED

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 0C1, Canada

COMPLETED

Hospital Internacional de Colombia

Piedecuesta, Colombia

NOT YET RECRUITING

Mayo University Hospital

Castlebar, F23 H529, Ireland

RECRUITING

Cork University Hospital

Cork, T12 DFK4, Ireland

COMPLETED

Mater Misericordiae University Hospital

Dublin, D07 R2WY, Ireland

COMPLETED

Galway University Hospitals

Galway, H91 YR71, Ireland

COMPLETED

University Hospital Waterford

Waterford, X91 ER8E, Ireland

NOT YET RECRUITING

Southland Hospital

Invercargill, 9812, New Zealand

COMPLETED

Rotorua Hospital

Rotorua, 3010, New Zealand

NOT YET RECRUITING

Tan Tock Seng Hospital

Singapore, 308433, Singapore

COMPLETED

Royal United Hospitals Bath

Bath, BA1 3NG, United Kingdom

COMPLETED

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

COMPLETED

Study Officials

• Matteo Parotto, MD, PhD

  UHN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Parotto, MD, PhD

CONTACT

+1 416 340 3567; matteo.parotto@uhn.ca

Shayan Wasim, MPH, BSc

CONTACT

+1 416 340 4800; shayan.wasim@uhn.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: June 5, 2024
• Study Start: April 14, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (5); SG (1); GB (2); AU (6); US (6); CA (9); NZ (2); CO (1)