EXtubation Related Complications - the EXTUBE Study (EXTUBE)
NCT ID: NCT06442930
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
3000 participants
OBSERVATIONAL
2025-04-14
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 determine the incidence of severe extubation-related complications within 60 minutes after extubation in adults who have undergone mechanical ventilation for general anesthesia or 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 for tracheostomy decannulation
For each patient who is not included, reasons for exclusion will be reported.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Health Network, Toronto
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Matteo Parotto, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UHN
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Oregon Health & Science University
Portland, Oregon, United States
The University of Texas Health Science Center
Houston, Texas, United States
Royal North Shore Hospital
Sydney, New South Wales, Australia
The Northern Hospital
Melbourne, Victoria, Australia
Eastern Health - Box Hill Hospital
Melbourne, Victoria, Australia
Eastern Health - Maroondah Hospital
Melbourne, Victoria, Australia
Eastern Health - Angliss Hospital
Melbourne, Victoria, Australia
Surrey Memorial Hospital
Surrey, British Columbia, Canada
The Moncton Hospital
Moncton, New Brunswick, Canada
Niagara Health - Marotta Family Hospital
Saint Catharines, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada
University Health Network - Toronto Western Hospital
Toronto, Ontario, Canada
Galway University Hospitals
Galway, , Ireland
Tan Tock Seng Hospital
Singapore, , Singapore
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jennifer L Tsang, MD, PhD, FRCPC
Role: primary
William K Dechert, MSc
Role: backup
John Laffey, MD, MA, DSc, MRIA
Role: primary
Celia Thomas, MSc
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
4850
Identifier Type: OTHER
Identifier Source: secondary_id
24-5811
Identifier Type: -
Identifier Source: org_study_id