• The NEUROlogically-impaired Extubation Timing Trial

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  Unknown statusInterventionalNot ApplicableUpdated Feb 5, 2020
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ClinicalTrials.gov ID

NCT04291235

Lead Sponsor

Sunnybrook Health Sciences CentreOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

332Estimated

Last Update Posted

Mar 2, 2020Actual

Start Date

Apr 1, 2020Estimated

Primary Completion Date

Jan 1, 2023Estimated

Completion Date

Jan 1, 2023Estimated

Official Title

The NEUROlogically-impaired Extubation Timing Trial

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.

• Acute Brain Injury

• Airway Management Pathway
• Usual Care

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Health Services Research

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Sunnybrook Health Sciences CentreOTHER

Collaborators

Canadian Institutes of Health Research (CIHR)OTHER_GOV

sharmasun@hhsc.ca905-521-2100 ext. 44721

2jgb1@queensu.ca613-549-6666 ext. 6228

senglish@ohri.ca613-737-8726

bakera@smh.ca416-864-5559

Jeff.Singh@uhn.ca416-603-5800 ext. 3221

alexis.turgeon@fmed.ulaval.ca418-649-0252 ext. 66064