Acute Brain InjuryNCT04291235
The NEUROlogically-impaired Extubation Timing Trial (NEURO-ETT)
A study testing Airway Management Pathway in people with Acute Brain Injury, run by Sunnybrook Health Sciences Centre at 14 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Brain Injury
- What is being tested?
- Airway Management Pathway
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 14 sitesCanada
- Study dates
- 1 Apr 2020to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Canada14 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
David Zygun, MD, 780-492-8597, zygun@ualberta.ca
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 3A7
Laurel Murphey, MD, 902-473-3486, laurel.murphy@nshealth.ca
Hamilton General Hospital
Hamilton, Ontario, L8N 3Z5
Sunjay Sharma, MD, 905-521-2100 ext. 44721, sharmasun@hhsc.ca
Kingston General Hospital
Kingston, Ontario, K7L 2V7
J. Gordon Boyd, MD, 613-549-6666 ext. 6228, 2jgb1@queensu.ca
London Health Sciences Centre
London, Ontario, N6A 5A5
Karen Bosma, MD, 519-663-3531, Karenj.Bosma@lhsc.on.ca
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 2H8
Michaël Chassé, MD, 514-890-8000 ext. 30816, michael.chasse.chum@ssss.gouv.qc.ca
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5
Emmanuel Charbonney, MD, 514 338 2050, emmanuel.charbonney@umontreal.ca
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
Steven Reynolds, MD, steven.reynolds@fraserhealth.ca
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Shane English, MD, 613-737-8726, senglish@ohri.ca
L'Hôpital de l'Enfant-Jésus
Québec, Quebec, G1J 1Z4
Alexis Turgeon, MD, 418-649-0252 ext. 66064, alexis.turgeon@fmed.ulaval.ca
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Damon Scales, MD, 416-480-6100 ext. 5291, damon.scales@sunnybrook.ca
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Andrew Baker, MD, 416-864-5559, bakera@smh.ca
Toronto Western Hospital
Toronto, Ontario, M5G 2N2
Jeff Singh, MD, 416-603-5800 ext. 3221, Jeff.Singh@uhn.ca
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Donald Griesdale, MD, 604-875-4304, Donald.Griesdale@vch.ca
About this study
Official title: The NEUROlogically-impaired Extubation Timing Trial
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.
Read the detailed description
Thousands of patients suffer severe brain injuries every year, from causes such as trauma, stroke, and infection. These patients are usually not fully awake and need help with their breathing and with preventing them from choking on their secretions. This is done with a breathing tube inserted through the mouth into the lungs and connected to a breathing machine. As patients recover, It is often unclear when the best time is to remove the breathing tube. Doctors might decide to remove it relatively early, or they may wait until the patient is more fully awake, or they may perform a tracheostomy (neck surgery to insert a new tube directly into the windpipe (trachea), replacing the temporary breathing tube). Each of these approaches has risks and benefits. 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.
- Conditions
- Acute Brain Injury
- Being tested
- Airway Management Pathway, Usual Care
- Keywords
- 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
- Medical subject headings
- Brain Injuries, Subarachnoid Hemorrhage, Diffuse Axonal Injury, Ischemic Stroke, Cerebral Hemorrhage, Brain Neoplasms, Heart Arrest, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway Management PathwayProcedure or surgery
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.
Usual CareProcedure or surgery
Patients in this group will be treated according to usual care, which may include extubation or tracheostomy timed according to treating physicians' discretion.
| Study group | Role | What they receive |
|---|---|---|
| Airway Management Pathway | Active comparator | 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 Receives: Procedure: Airway Management Pathway |
| Usual Care | Active comparator | The 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 Receives: Procedure: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Duration of Mechanical Ventilation
Total duration of mechanical ventilation (to 60 days) accounting for the competing risk of death
Measured: Up to 60 Days
Secondary outcomes (12)
Mortality at ICU discharge and Hospital Discharge
Mortality at ICU Discharge, Hospital Discharge, 3 months, and 6 months
Measured: ICU Discharge, Hospital Discharge, 3 months, and 6 months
Ventilator-Free Days at Day 60
Days alive and not receiving mechanical ventilation
Measured: Up to 60 days
ICU Free Days At Day 60
ICU free days (days alive and not spent in an ICU)
Measured: Up to 60 Days
Airway or Tracheostomy complications
Presence versus absence of airway complication
Measured: Up to 30 days
Nutrition Intake
Time to normal oral nutrition intake
Measured: Up to 6 Months
Antibiotics Days
Injection or infusion of antibiotics given intravenously
Measured: Up to 30 Days
Tracheostomy Rates
Presence versus absence of tracheostomy insertion
Measured: Up to 6 Months
ICU Readmission Rates
ICU readmission rates to hospital discharge
Measured: Hospital discharge, up to 90 days
Discharge Destination
Discharge destination for the patient post hospitalization
Measured: Hospital discharge, up to 90 days
Extended Glasgow Outcome Score
Minimum score 1 (worst) to maximum score 8 (best) at 3 months and 6 months
Measured: 3 months and 6 months
EuroQol-5D
Minimum score 1 (worst) to maximum score 100 (best) at 3 months and 6 months
Measured: 3 months and 6 months
Delirium Free Days
Days alive and free of delirium while in ICU up to day 30
Measured: Up to 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dr. Damon Scales, Sunnybrook Health Sciences Centre
- Investigators
- Niall Ferguson, MD, MSc, Principal investigator, Toronto General HospitalDamon Scales, MD, PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291235
- Sponsor's protocol ID
- NEURO-ETT
- Status last verified
- Feb 2020
- First submitted
- 3 Feb 2020
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39585965
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NEUROlogically-impaired Extubation Timing Trial
- ClinicalTrials.gov ID
- NCT04291235
- Acronym / sponsor ID
- NEURO-ETT
- Conditions
- Acute Brain Injury
- Keywords
- Subarachnoid Hemorrhage, Diffuse Axonal Injury, Ischemic Stroke, Intracerebral Hemorrhage, Brain Tumor, Global Cerebral Anoxia/Cardiac Arrest, Meningitis/Encephalitis, Cerebral Abscess
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Thousands of patients suffer severe brain injuries every year, from causes such as trauma, stroke, and infection. These patients are usually not fully awake and need help with their breathing and with preventing them from choking on their secretions. This is done with a breathing tube inserted through the mouth into the lungs and connected to a breathing machine. As patients recover, It is often unclear when the best time is to remove the breathing tube. Doctors might decide to remove it relatively early, or they may wait until the patient is more fully awake, or they may perform a tracheostomy (neck surgery to insert a new tube directly into the windpipe (trachea), replacing the temporary breathing tube). Each of these approaches has risks and benefits. 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airway Management Pathway | Active comparator | Procedure: Airway Management PathwayAn 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 comparator | Procedure: Usual CareThe 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Airway Management PathwayPatients 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. | Procedure or surgery | Airway Management Pathway |
| Usual CarePatients in this group will be treated according to usual care, which may include extubation or tracheostomy timed according to treating physicians' discretion. | Procedure or surgery | Usual Care |
Primary outcome
Total Duration of Mechanical Ventilation
Time frame: Up to 60 Days
Total duration of mechanical ventilation (to 60 days) accounting for the competing risk of death
12 secondary outcomes
Mortality at ICU discharge and Hospital Discharge
Time frame: ICU Discharge, Hospital Discharge, 3 months, and 6 months
Ventilator-Free Days at Day 60
Time frame: Up to 60 days
ICU Free Days At Day 60
Time frame: Up to 60 Days
Airway or Tracheostomy complications
Time frame: Up to 30 days
Nutrition Intake
Time frame: Up to 6 Months
Antibiotics Days
Time frame: Up to 30 Days
Tracheostomy Rates
Time frame: Up to 6 Months
ICU Readmission Rates
Time frame: Hospital discharge, up to 90 days
Discharge Destination
Time frame: Hospital discharge, up to 90 days
Extended Glasgow Outcome Score
Time frame: 3 months and 6 months
EuroQol-5D
Time frame: 3 months and 6 months
Delirium Free Days
Time frame: Up to 30 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Derived from this study: PubMed 39585965Angriman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niall Ferguson, MD, MSc principal investigator
Toronto General Hospital
Damon Scales, MD, PhD principal investigator
Sunnybrook Health Sciences Centre
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airway Management Pathway in people with Acute Brain Injury, run by Sunnybrook Health Sciences Centre at 14 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Venika Manoharan, HBSc (416-480-6100 ext. 88136, venika.manoharan@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Duration of Mechanical Ventilation (time frame: Up to 60 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04291235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020.