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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 16 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04291235
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sunnybrook Health Sciences Centre
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Niall Ferguson, MD, MScDamon Scales, MD, PhD
Principal Investigator Affiliation Toronto General HospitalSunnybrook Health Sciences Centre
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Acute Brain Injury
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: 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

Active Comparator: 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

Interventions

Procedure: - 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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University of Alberta Hospital, Edmonton, Alberta, Canada

Status

Address

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7

Site Contact

David Zygun, MD

zygun@ualberta.ca

780-492-8597

Royal Columbian Hospital, New Westminster, British Columbia, Canada

Status

Address

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7

Site Contact

Steven Reynolds, MD

steven.reynolds@fraserhealth.ca

416-480-6100

Vancouver General Hospital, Vancouver, British Columbia, Canada

Status

Address

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9

Site Contact

Donald Griesdale, MD

Donald.Griesdale@vch.ca

604-875-4304

Nova Scotia Health Authority, Halifax, Nova Scotia, Canada

Status

Address

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 3A7

Site Contact

Laurel Murphey, MD

laurel.murphy@nshealth.ca

902-473-3486

Hamilton General Hospital, Hamilton, Ontario, Canada

Status

Address

Hamilton General Hospital

Hamilton, Ontario, L8N 3Z5

Site Contact

Sunjay Sharma, MD

sharmasun@hhsc.ca

905-521-2100 #44721

Kingston General Hospital, Kingston, Ontario, Canada

Status

Address

Kingston General Hospital

Kingston, Ontario, K7L 2V7

Site Contact

J. Gordon Boyd, MD

2jgb1@queensu.ca

613-549-6666 #6228

London Health Sciences Centre, London, Ontario, Canada

Status

Address

London Health Sciences Centre

London, Ontario, N6A 5A5

Site Contact

Karen Bosma, MD

Karenj.Bosma@lhsc.on.ca

519-663-3531

Ottawa Hospital, Ottawa, Ontario, Canada

Status

Address

Ottawa Hospital

Ottawa, Ontario, K1H 8L6

Site Contact

Shane English, MD

senglish@ohri.ca

613-737-8726

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Status

Address

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5

Site Contact

Damon Scales, MD

damon.scales@sunnybrook.ca

416-480-6100 #5291

St. Michael's Hospital, Toronto, Ontario, Canada

Status

Address

St. Michael's Hospital

Toronto, Ontario, M5B 1W8

Site Contact

Andrew Baker, MD

bakera@smh.ca

416-864-5559

Toronto Western Hospital, Toronto, Ontario, Canada

Status

Address

Toronto Western Hospital

Toronto, Ontario, M5G 2N2

Site Contact

Jeff Singh, MD

Jeff.Singh@uhn.ca

416-603-5800 #3221

Hôpital du Sacré-Coeur de Montréal, Montreal, Quebec, Canada

Status

Address

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5

Site Contact

Emmanuel Charbonney, MD

emmanuel.charbonney@umontreal.ca

514 338 2050

Montréal, Quebec, Canada

Status

Address

Centre hospitalier de l'Université de Montréal

Montréal, Quebec, H2X 2H8

Site Contact

Michaël Chassé, MD

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

514-890-8000 #30816

L'Hôpital de l'Enfant-Jésus, Quebec City, Quebec, Canada

Status

Address

L'Hôpital de l'Enfant-Jésus

Quebec City, Quebec, G1J 1Z4

Site Contact

Alexis Turgeon, MD

alexis.turgeon@fmed.ulaval.ca

418-649-0252 #66064

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