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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06442930
Registration number
NCT06442930
Ethics application status
Date submitted
28/03/2024
Date registered
5/06/2024
Date last updated
10/09/2025
Titles & IDs
Public title
EXtubation Related Complications - the EXTUBE Study (EXTUBE)
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Scientific 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
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Secondary ID [1]
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4850
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Secondary ID [2]
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24-5811
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Universal Trial Number (UTN)
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Trial acronym
EXTUBE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Extubation
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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At least one of the following, occurring within 60minutes after extubation (composite outcome): i) Severe hypoxemia ii) Cardiac arrest iii) Need for airway management
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Assessment method [1]
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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%) ii) Cardiac arrest iii) Need for airway management (reintubation, insertion of a supraglottic airway, bag-mask ventilation).
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Timepoint [1]
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Within 60 minutes after the end of extubation
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Secondary outcome [1]
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Difficult airway and complications related to airway management if reintubation is required
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Assessment method [1]
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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
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Timepoint [1]
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Within 60 minutes after the end of extubation
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Secondary outcome [2]
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Planned and unplanned non-invasive respiratory support
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Assessment method [2]
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Planned and unplanned non-invasive respiratory support or high flow nasal cannula
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Timepoint [2]
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Within 60 minutes after the end of extubation
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Secondary outcome [3]
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Emergency front of neck airway
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Assessment method [3]
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Emergency front of neck airway should airway management be required after extubation
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Timepoint [3]
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Within 60 minutes after the end of extubation
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Secondary outcome [4]
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Cardiac arrhythmia requiring chemical or electrical treatment
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Assessment method [4]
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Cardiac arrhythmia requiring chemical or electrical treatment
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Timepoint [4]
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Within 60 minutes after the end of extubation
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Secondary outcome [5]
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Severe Hypotension
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Assessment method [5]
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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)
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Timepoint [5]
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Within 60 minutes after the end of extubation
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Secondary outcome [6]
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Severe Hypertension
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Assessment method [6]
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Severe hypertension (systolic blood pressure =180 mmHg and/or diastolic blood pressure =120 mmHg),
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Timepoint [6]
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Within 60 minutes after the end of extubation
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Secondary outcome [7]
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Pulmonary aspiration
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Assessment method [7]
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Aspiration of gastric contents (gastric contents inhaled into the larynx and the respiratory tract)
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Timepoint [7]
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Within 60 minutes after the end of extubation
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Secondary outcome [8]
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Barotrauma
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Assessment method [8]
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Pneumothorax/pneumo-mediastinum
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Timepoint [8]
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Within 60 minutes after the end of extubation
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Secondary outcome [9]
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Dental injury
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Assessment method [9]
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Dental injury (notable change to the patient's dentition attributable to extubation or to reintubation, should this be required)
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Timepoint [9]
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Within 60 minutes after the end of extubation
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Secondary outcome [10]
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Airways injury
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Assessment method [10]
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Airways injury (e.g., vocal cord damage, arytenoid dislocation
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Timepoint [10]
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Within 60 minutes after the end of extubation
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Secondary outcome [11]
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Mortality
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Assessment method [11]
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In-hospital mortality
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Timepoint [11]
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Within 7 days after extubation
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Secondary outcome [12]
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Re-intubation
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Assessment method [12]
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Re-intubation within 48 hours of extubation
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Timepoint [12]
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Within 48 hours after extubation
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/04/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2026
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Actual
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Sample size
Target
3000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Eastern Health - Box Hill Hospital - Melbourne
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Recruitment hospital [2]
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Eastern Health - Maroondah Hospital - Melbourne
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Recruitment hospital [3]
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Eastern Health - Angliss Hospital - Melbourne
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Recruitment postcode(s) [1]
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3128 - Melbourne
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Recruitment postcode(s) [2]
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3135 - Melbourne
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Recruitment postcode(s) [3]
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3156 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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Country [2]
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United States of America
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State/province [2]
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Oregon
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Country [3]
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United States of America
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State/province [3]
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Texas
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Country [4]
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Canada
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State/province [4]
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New Brunswick
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Country [5]
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Canada
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State/province [5]
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Ontario
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Country [6]
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Singapore
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State/province [6]
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Singapore
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Funding & Sponsors
Primary sponsor type
Other
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Name
University Health Network, Toronto
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT06442930
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Matteo Parotto, MD, PhD
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Address
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UHN
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Matteo Parotto, MD, PhD
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Address
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Country
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Phone
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+1 416 340 3567
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06442930
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