Acute Brain InjuryNEURO-ETTNCT02920580
The NEUROlogically-impaired Extubation Timing Trial
A study testing Extubation in people with Acute Brain Injury, run by Sunnybrook Health Sciences Centre at 13 sites in Canada.
Trial summary
This randomized controlled trial will enrol patients with acute severe brain injury who pass a spontaneous breathing trial but have decreased level of consciousness. It will directly compare (1) prompt extubation vs. (2) usual care, with extubation or tracheostomy timed according to physicians' discretion. 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?
- Extubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 13 sitesCanada
- Study dates
- 1 Feb 2017to 31 Jan 2022
- 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, ischemic stroke, spontaneous intracerebral hemorrhage, seizure, traumatic brain injury, brain tumor, global cerebral anoxia/cardiac arrest, meningitis/encephalitis/cerebral abscess) that occurred within the previous 4 weeks.
- Receiving invasive mechanical ventilation via endotracheal tube for > 72 hours
- Glasgow Coma Scale motor score 3 to 6 with improvement or no change from previous day
- passed spontaneous breathing trial (SBT)
Who cannot join
- Previous extubation during this ICU admission
- 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 expected mortality less than 6-months.
Show all 12Show fewer
- Anticipated/scheduled for surgical procedures within 48 hours
- C-spine not yet cleared for activity as tolerated (cleared for activity as tolerated while wearing hard collar is acceptable)
- Currently known or suspected to have an difficult airway
- Absence of an endotracheal tube cuff leak, if checked
- Absence of spontaneous or induced cough
- Current enrolment in an RCT that precludes NEURO-ETT co-enrollment
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Canada13 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Hamilton General Hospital
Hamilton, Ontario, L8N 3Z5
Kingston General Hospital
Kingston, Ontario, K7L 2V7
London Health Sciences Centre
London, Ontario, N6A 5A5
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 2H8
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, H4J 1C5
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
L'Hôpital de l'Enfant-Jésus
Québec, Quebec, G1J 1Z4
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Toronto Western Hospital
Toronto, Ontario, M5G 2N2
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
This randomized controlled trial will enrol patients with acute severe brain injury who pass a spontaneous breathing trial but have decreased level of consciousness. It will directly compare (1) prompt extubation vs. (2) usual care, with extubation or tracheostomy timed according to physicians' discretion. The primary outcome will be ICU free days (days spent alive and outside an ICU).
Read the detailed description
Thousands of patients suffer severe brain injuries every year, from causes such as trauma, stroke, and infection. Extensive clinical research in weaning from mechanical ventilation has led to recommendations for prompt extubation following a successful trial of spontaneous breathing in general intensive care unit (ICU). However, little evidence exists to guide decisions about when to remove the breathing tube in patients with severe brain injury. It is unclear which of the following strategies would optimize important patient outcomes: prompt extubation vs. waiting and extubating or performing a tracheostomy, timed according to physicians' discretion. Each strategy has associated risks: prompt extubation may lead to higher rates of extubation failure and reintubation, whereas waiting longer may expose patients to complications from prolonged mechanical ventilation and tracheostomy may lead to procedural complications (or unnecessary procedures, if prompt extubation would be successful). This trial in brain-injured patients will test which of the following will lead to better patient outcomes: (1) removing the endotracheal tube promptly once a spontaneous breathing trial is passed; or (2) usual care, with the airway management strategy selected according to the preference of the treating physician.
- Conditions
- Acute Brain Injury
- Being tested
- Extubation, Usual Care
- Keywords
- Subarachnoid hemorrhage, Spontaneous intracerebral hemorrhage, Global cerebral anoxia/cardiac arrest, Meningitis/Encephalitis/Cerebral abscess, Seizure, Traumatic Brain Injury (TBI), Ischemic Stroke, Brain tumor
- Medical subject headings
- Brain Injuries, Subarachnoid Hemorrhage, Heart Arrest, Meningitis, Seizures, Brain Injuries, Traumatic, Ischemic Stroke, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExtubationProcedure or surgery
This is an extubation by removal of endotracheal tube which must be done on the day of randomization or the following day. Any decision to subsequently reintubate the patient will be left to the discretion of the clinical team. Similarly, if a tracheostomy is deemed necessary in a patient who fails the extubation attempt, this will be managed at the discretion of the treating team. If for any reason the patient is not extubated according to the randomized schedule, the reason(s) will be recorded on a protocol violation form and the site investigator will be notified. If a patient receives a tracheostomy instead of being extubated we will again record reasons for this, but the patient will be analysed in the extubation group according to the intention-to-treat principle.
Usual CareProcedure or surgery
Patients in this group will be treated according to usual care, which may include extubation (removal of endotracheal tube) or insertion of a tracheostomy, timed according to physicians' discretion. The inclusion of this arm will allow prompt extubation to be compared to usual practice, which often involves further observation and delayed decision-making due to clinician uncertainty about the optimal airway management strategy. Incorporation of usual care arms has been promoted as a design feature to improve the safety and interpretability of critical care clinical trials.
| Study group | Role | What they receive |
|---|---|---|
| Extubation | Active comparator | Extubation by removal of endotracheal tube. Receives: Procedure: Extubation |
| Usual care | Active comparator | The usual clinical practice is removal of the endotracheal tube (extubation), or insertion of tracheostomy, timed according to physicians' discretion Receives: Procedure: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Free Days
The primary outcome is number of ICU free days to day 60, defined as the number of days spent alive and outside of an ICU until day 60.
The primary outcome will be measured to answer the following primary question: Among patients receiving minimal mechanical ventilatory support for severe and persistent brain injury, which of the following airway management strategies increase ICU-free days to day 60: (1) prompt extubation vs. (2) usual care, which may include extubation or tracheostomy timed according to physicians' discretion?
Measured: 60 days
Secondary outcomes (11)
Mortality,
Mortality at ICU discharge, mortality at hospital discharge, mortality at 3 months, mortality at 6 months
Measured: up to 6 months
Ventilator-Free Days
Days free of mechanical ventilation, total duration (days) of ventilation among survivors
Measured: up to 60 days
Airway Complications
Presence versus absence of airway complication
Measured: up to 60 days
Nutrition Intake
Time to normal oral nutrition intake
Measured: up to 6 months
Antibiotic Days
Injection or infusion of antibiotics given intravenously
Measured: up to day 14
Delirium
Presence versus absence of delirium experienced
Measured: up to day 14
Rate of Tracheostomy Insertion
Presence versus absence of tracheostomy insertion
Measured: up to 6 months
Rate of ICU Readmission
ICU readmission rates to hospital discharge
Measured: up to hospital discharge
Hospital Discharge Destination
Destination of the patient post hospitalization - home, rehabilitation facility, retirement home, long-term care/nursing home, no fixed address or shelter, continuing complex care, acute care hospital, other
Measured: at hospital discharge
Extended Glasgow Outcome Score
Functional outcome (scoring 1 to 8)
Measured: up to 6 months
EQ-5D
Health related quality of life (scoring 1 to 5)
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study start1 Feb 2017
- Primary completion19 Jun 2019
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
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
- NCT02920580
- Sponsor's protocol ID
- NEURO-ETT (Vanguard)
- Acronym
- NEURO-ETT
- Status last verified
- Feb 2020
- First submitted
- 22 Sep 2016
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 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
- NCT02920580
- Acronym / sponsor ID
- NEURO-ETT / NEURO-ETT (Vanguard)
- Conditions
- Acute Brain Injury
- Keywords
- Subarachnoid hemorrhage, Spontaneous intracerebral hemorrhage, Global cerebral anoxia/cardiac arrest, Meningitis/Encephalitis/Cerebral abscess, Seizure, Traumatic Brain Injury (TBI), Ischemic Stroke, Brain tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 30 Sep 2016 (estimated)
- 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 randomized controlled trial will enrol patients with acute severe brain injury who pass a spontaneous breathing trial but have decreased level of consciousness. It will directly compare (1) prompt extubation vs. (2) usual care, with extubation or tracheostomy timed according to physicians' discretion. The primary outcome will be ICU free days (days spent alive and outside an ICU).
Detailed description
Thousands of patients suffer severe brain injuries every year, from causes such as trauma, stroke, and infection. Extensive clinical research in weaning from mechanical ventilation has led to recommendations for prompt extubation following a successful trial of spontaneous breathing in general intensive care unit (ICU). However, little evidence exists to guide decisions about when to remove the breathing tube in patients with severe brain injury. It is unclear which of the following strategies would optimize important patient outcomes: prompt extubation vs. waiting and extubating or performing a tracheostomy, timed according to physicians' discretion. Each strategy has associated risks: prompt extubation may lead to higher rates of extubation failure and reintubation, whereas waiting longer may expose patients to complications from prolonged mechanical ventilation and tracheostomy may lead to procedural complications (or unnecessary procedures, if prompt extubation would be successful). This trial in brain-injured patients will test which of the following will lead to better patient outcomes: (1) removing the endotracheal tube promptly once a spontaneous breathing trial is passed; or (2) usual care, with the airway management strategy selected according to the preference of the treating physician.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extubation | Active comparator | Procedure: ExtubationExtubation by removal of endotracheal tube. |
| Usual care | Active comparator | Procedure: Usual CareThe usual clinical practice is removal of the endotracheal tube (extubation), or insertion of tracheostomy, timed according to physicians' discretion |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 16 years
- Acute brain injury (subarachnoid hemorrhage, ischemic stroke, spontaneous intracerebral hemorrhage, seizure, traumatic brain injury, brain tumor, global cerebral anoxia/cardiac arrest, meningitis/encephalitis/cerebral abscess) that occurred within the previous 4 weeks.
- Receiving invasive mechanical ventilation via endotracheal tube for > 72 hours
- Glasgow Coma Scale motor score 3 to 6 with improvement or no change from previous day
- passed spontaneous breathing trial (SBT)
Key exclusion criteria (12 listed)
- Previous extubation during this ICU admission
- 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
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 |
|---|---|---|
| ExtubationThis is an extubation by removal of endotracheal tube which must be done on the day of randomization or the following day. Any decision to subsequently reintubate the patient will be left to the discretion of the clinical team. Similarly, if a tracheostomy is deemed necessary in a patient who fails the extubation attempt, this will be managed at the discretion of the treating team. If for any reason the patient is not extubated according to the randomized schedule, the reason(s) will be recorded on a protocol violation form and the site investigator will be notified. If a patient receives a tracheostomy instead of being extubated we will again record reasons for this, but the patient will be analysed in the extubation group according to the intention-to-treat principle. | Procedure or surgery | Extubation |
| Usual CarePatients in this group will be treated according to usual care, which may include extubation (removal of endotracheal tube) or insertion of a tracheostomy, timed according to physicians' discretion. The inclusion of this arm will allow prompt extubation to be compared to usual practice, which often involves further observation and delayed decision-making due to clinician uncertainty about the optimal airway management strategy. Incorporation of usual care arms has been promoted as a design feature to improve the safety and interpretability of critical care clinical trials. | Procedure or surgery | Usual care |
Primary outcome
ICU Free Days
Time frame: 60 days
The primary outcome is number of ICU free days to day 60, defined as the number of days spent alive and outside of an ICU until day 60. The primary outcome will be measured to answer the following primary question: Among patients receiving minimal mechanical ventilatory support for severe and persistent brain injury, which of the following airway management strategies increase ICU-free days to day 60: (1) prompt extubation vs. (2) usual care, which may include extubation or tracheostomy timed according to physicians' discretion?
11 secondary outcomes
Mortality,
Time frame: up to 6 months
Ventilator-Free Days
Time frame: up to 60 days
Airway Complications
Time frame: up to 60 days
Nutrition Intake
Time frame: up to 6 months
Antibiotic Days
Time frame: up to day 14
Delirium
Time frame: up to day 14
Rate of Tracheostomy Insertion
Time frame: up to 6 months
Rate of ICU Readmission
Time frame: up to hospital discharge
Hospital Discharge Destination
Time frame: at hospital discharge
Extended Glasgow Outcome Score
Time frame: up to 6 months
EQ-5D
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- 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
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extubation in people with Acute Brain Injury, run by Sunnybrook Health Sciences Centre at 13 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 5 inclusion and 12 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Free Days (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2020; AzTrials last refreshed its copy on 31 Oct 2026.