EXtubation Related Complications - the EXTUBE Study (EXTUBE) (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 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).

Study Overview

• Status: Recruiting
• Conditions: Extubation

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Matteo Parotto, MD, PhD; Phone Number: +1 416 340 3567; Email: matteo.parotto@uhn.ca
• Study Contact Backup: Name: Shayan Wasim, MPH, BSc; Phone Number: 4221 +1 416 340 4800; Email: shayan.wasim@uhn.ca

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2065
      • Completed
      • Royal North Shore Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3135
      • Completed
      • Eastern Health - Maroondah Hospital
    • Melbourne, Victoria, Australia, 3156
      • Completed
      • Eastern Health - Angliss Hospital
    • Melbourne, Victoria, Australia, 3076
      • Completed
      • The Northern Hospital
    • Melbourne, Victoria, Australia, 3128
      • Completed
      • Eastern Health - Box Hill Hospital
    • Melbourne, Victoria, Australia, 3084
      • Completed
      • Austin Hospital
• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 1Z2
      • Completed
      • Surrey Memorial Hospital
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 4B7
      • Completed
      • The Moncton Hospital
  • Ontario
    • North York, Ontario, Canada, M4N 3M5
      • Completed
      • Sunnybrook Hospital
    • Saint Catharines, Ontario, Canada, L2S 0A9
      • Completed
      • Niagara Health - Marotta Family Hospital
    • Toronto, Ontario, Canada, M5G 2C4
      • Completed
      • University Health Network - Toronto General Hospital
    • Toronto, Ontario, Canada, M5G 1X5
      • Completed
      • Mount Sinai Hospital
    • Toronto, Ontario, Canada, M5B 1W8
      • Completed
      • St. Michael's Hospital
    • Toronto, Ontario, Canada, M5T 2S8
      • Completed
      • University Health Network - Toronto Western Hospital
  • Quebec
    • Montreal, Quebec, Canada, H2X 0C1
      • Completed
      • Centre Hospitalier de l'Universite de Montreal (CHUM)
• Ireland
  • Castlebar, Ireland, F23 H529
    • Active, not recruiting
    • Mayo University Hospital
  • Cork, Ireland, T12 DFK4
    • Completed
    • Cork University Hospital
  • Dublin, Ireland, D07 R2WY
    • Completed
    • Mater Misericordiae University Hospital
  • Galway, Ireland, H91 YR71
    • Completed
    • Galway University Hospitals
• New Zealand
  • Invercargill, New Zealand, 9812
    • Completed
    • Southland Hospital
• Singapore
  • Singapore, Singapore, 308433
    • Completed
    • Tan Tock Seng Hospital
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • Completed
    • Royal United Hospitals Bath
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Completed
    • Freeman Hospital
• United States
  • Arizona
    • Tucson, Arizona, United States, 85724-5114
      • Completed
      • Banner University Medical Centre
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Completed
      • University of Arkansas for Medical Sciences
  • Florida
    • Gainesville, Florida, United States, 32608
      • Completed
      • University of Florida
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • The University of Chicago
      • Contact: Danisa Daubenspeck, D.O; Phone Number: 773-702-6700; Email: ddaubenspeck@bsd.uchicago.edu
      • Contact: Somayeh Mohammadi, M.D; Email: mohammadis@bsd.uchicago.edu
      • Principal Investigator: Danisa Daubenspeck, D.O
      • Sub-Investigator: Victoria R Hans, D.O
  • Oregon
    • Portland, Oregon, United States, 97239
      • Completed
      • Oregon Health & Science University
  • Texas
    • Houston, Texas, United States, 77030
      • Completed
      • The University of Texas Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency front of neck airway	Emergency front of neck airway should airway management be required after extubation	Within 60 minutes after the end of extubation
Cardiac arrhythmia requiring chemical or electrical treatment	Cardiac arrhythmia requiring chemical or electrical treatment	Within 60 minutes after the end of extubation
Pulmonary aspiration	Aspiration of gastric contents (gastric contents inhaled into the larynx and the respiratory tract)	Within 60 minutes after the end of extubation
Barotrauma	Pneumothorax/pneumo-mediastinum	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)	Within 60 minutes after the end of extubation
Mortality	In-hospital mortality	Within 7 days after extubation
Re-intubation	Re-intubation within 48 hours of extubation	Within 48 hours after 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	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	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)	Within 60 minutes after the end of extubation
Severe Hypertension	Severe hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥120 mmHg),	Within 60 minutes after the end of extubation
Airways injury	Airways injury (e.g., vocal cord damage, arytenoid dislocation	Within 60 minutes after the end of extubation

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Matteo Parotto, MD, PhD, UHN

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 24-5811; 4850 (Other Identifier: Clinical Trials Ontario - CTO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No