The NEUROlogically-impaired Extubation Timing Trial (NEURO-ETT)

NCT ID: NCT04291235

Last Updated: 2020-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 332 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2023-01-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Airway Management Pathway

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

Group Type: ACTIVE_COMPARATOR

Airway Management Pathway

Intervention Type: PROCEDURE

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 Care

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: PROCEDURE

Patients in this group will be treated according to usual care, which may include extubation or tracheostomy timed according to treating physicians' discretion.

Interventions

Airway Management Pathway

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.

Intervention Type: PROCEDURE

Usual Care

Patients in this group will be treated according to usual care, which may include extubation or tracheostomy timed according to treating physicians' discretion.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age > 16 years

2. 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

3. Receiving mechanical ventilation via endotracheal tube for ≥ 48 hours

Exclusion Criteria

1. Quadriplegic

2. 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

3. Do-Not-Reintubate order in place

4. Previously randomized in this trial

5. Underlying pre-existing condition with life expectancy less than 6-months

6. Current enrolment in an RCT that precludes NEURO-ETT co-enrollment

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Damon Scales

Chief of Critical Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Niall Ferguson, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Toronto General Hospital

Damon Scales, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

University of Alberta Hospital

Edmonton, Alberta, Canada

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Hamilton General Hospital

Hamilton, Ontario, Canada

Kingston General Hospital

Kingston, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

Ottawa Hospital

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, Canada

L'Hôpital de l'Enfant-Jésus

Québec, Quebec, Canada

Countries

Canada

Central Contacts

Venika Manoharan, HBSc

Role: CONTACT

venika.manoharan@sunnybrook.ca

416-480-6100 ext. 88136

Facility Contacts

David Zygun, MD

Role: primary

zygun@ualberta.ca

780-492-8597

Steven Reynolds, MD

Role: primary

steven.reynolds@fraserhealth.ca

Donald Griesdale, MD

Role: primary

Donald.Griesdale@vch.ca

604-875-4304

Laurel Murphey, MD

Role: primary

laurel.murphy@nshealth.ca

902-473-3486

Sunjay Sharma, MD

Role: primary

sharmasun@hhsc.ca

905-521-2100 ext. 44721

J. Gordon Boyd, MD

Role: primary

2jgb1@queensu.ca

613-549-6666 ext. 6228

Karen Bosma, MD

Role: primary

Karenj.Bosma@lhsc.on.ca

519-663-3531

Shane English, MD

Role: primary

senglish@ohri.ca

613-737-8726

Damon Scales, MD

Role: primary

damon.scales@sunnybrook.ca

416-480-6100 ext. 5291

Andrew Baker, MD

Role: primary

bakera@smh.ca

416-864-5559

Jeff Singh, MD

Role: primary

Jeff.Singh@uhn.ca

416-603-5800 ext. 3221

Michaël Chassé, MD

Role: primary

michael.chasse.chum@ssss.gouv.qc.ca

514-890-8000 ext. 30816

Emmanuel Charbonney, MD

Role: primary

emmanuel.charbonney@umontreal.ca

514 338 2050

Alexis Turgeon, MD

Role: primary

alexis.turgeon@fmed.ulaval.ca

418-649-0252 ext. 66064

References

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.

Reference Type: DERIVED

PMID: 39585965 (View on PubMed)

Other Identifiers

NEURO-ETT

Identifier Type: -

Identifier Source: org_study_id