The NEUROlogically-impaired Extubation Timing Trial (NEURO-ETT)
1 other identifier
interventional
332
1 country
14
Brief Summary
This trial in brain-injured patients will test which of the following will lead to better patient outcomes: (1) an airway management pathway consisting of daily assessments and removal of the breathing tube as soon as patients can breathe on their own and appear able to protect their airway; versus (2) the usual treatment patients would have received if they were not enrolled in this trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2020
Typical duration for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2020
CompletedFirst Posted
Study publicly available on registry
March 2, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedMarch 2, 2020
February 1, 2020
2.8 years
February 3, 2020
February 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Duration of Mechanical Ventilation
Total duration of mechanical ventilation (to 60 days) accounting for the competing risk of death
Up to 60 Days
Secondary Outcomes (12)
Mortality at ICU discharge and Hospital Discharge
ICU Discharge, Hospital Discharge, 3 months, and 6 months
Ventilator-Free Days at Day 60
Up to 60 days
ICU Free Days At Day 60
Up to 60 Days
Airway or Tracheostomy complications
Up to 30 days
Nutrition Intake
Up to 6 Months
- +7 more secondary outcomes
Study Arms (2)
Airway Management Pathway
ACTIVE COMPARATORAn airway management pathway consisting of daily assessments and removal of the breathing tube as soon as patients can breathe on their own and appear able to protect their airway
Usual Care
ACTIVE COMPARATORThe usual clinical practice is often to keep the patient on artificial respiration for longer in the hope that the patient will wake up before removing the tube, or performing a tracheostomy if the patient doesn't wake up
Interventions
Patients in this group will receive several components that comprise airway management pathway: (1) daily spontaneous breathing trials (SBTs); (2) prompt extubation following successful extubation readiness criteria; (3) high-flow nasal oxygen for at least 24 hours following extubation.
Patients in this group will be treated according to usual care, which may include extubation or tracheostomy timed according to treating physicians' discretion.
Eligibility Criteria
You may qualify if:
- Age \> 16 years
- Acute brain injury (subarachnoid hemorrhage, diffuse axonal injury, ischemic stroke, intracerebral hemorrhage, brain tumor, global cerebral anoxia/cardiac arrest, meningitis/encephalitis, cerebral abscess, epidural hematoma, subdural hematoma, seizure) that occurred within the previous 4 weeks
- Receiving mechanical ventilation via endotracheal tube for ≥ 48 hours
You may not qualify if:
- Quadriplegic
- Neuromuscular disease that will result in prolong need for mechanical ventilation, including but not limited to Guillain-Barre syndrome, cervical spinal cord injury, advanced multiple sclerosis
- Do-Not-Reintubate order in place
- Previously randomized in this trial
- Underlying pre-existing condition with life expectancy less than 6-months
- Current enrolment in an RCT that precludes NEURO-ETT co-enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 3A7, Canada
Hamilton General Hospital
Hamilton, Ontario, L8N 3Z5, Canada
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Toronto Western Hospital
Toronto, Ontario, M5G 2N2, Canada
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 2H8, Canada
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5, Canada
L'Hôpital de l'Enfant-Jésus
Québec, Quebec, G1J 1Z4, Canada
Related Publications (1)
Angriman F, Amaral ACKB, Fan E, Taran S, McCredie VA, Baker A, Bosma KJ, Brochard LJ, Adhikari NKJ, Cuthbertson BH, Scales DC, Ferguson ND. Timing of Extubation in Adult Patients with Acute Brain Injury. Am J Respir Crit Care Med. 2025 Mar;211(3):339-346. doi: 10.1164/rccm.202408-1553OC.
PMID: 39585965DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Niall Ferguson, MD, MSc
Toronto General Hospital
- PRINCIPAL INVESTIGATOR
Damon Scales, MD, PhD
Sunnybrook Health Sciences Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Critical Care Medicine
Study Record Dates
First Submitted
February 3, 2020
First Posted
March 2, 2020
Study Start
April 1, 2020
Primary Completion
January 1, 2023
Study Completion
January 1, 2023
Last Updated
March 2, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share