Clinical trial NCT04291235: The NEUROlogically-impaired Extubation Timing Trial (NEURO-ETT)
Official title: The NEUROlogically-impaired Extubation Timing Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Epidural Hematoma
Subdural Hematoma
Seizure
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2020-03-02
Enrollment: 332
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 outcomes:
measure: Total Duration of Mechanical Ventilation
timeFrame: Up to 60 Days
Secondary outcomes:
measure: Mortality at ICU discharge and Hospital Discharge
timeFrame: ICU Discharge, Hospital Discharge, 3 months, and 6 months
measure: Ventilator-Free Days at Day 60
timeFrame: Up to 60 days
measure: ICU Free Days At Day 60
timeFrame: Up to 60 Days
measure: Airway or Tracheostomy complications
timeFrame: Up to 30 days
measure: Nutrition Intake
timeFrame: Up to 6 Months
measure: Antibiotics Days
timeFrame: Up to 30 Days
measure: Tracheostomy Rates
timeFrame: Up to 6 Months
measure: ICU Readmission Rates
timeFrame: Hospital discharge, up to 90 days
measure: Discharge Destination
timeFrame: Hospital discharge, up to 90 days
measure: Extended Glasgow Outcome Score
timeFrame: 3 months and 6 months
measure: EuroQol-5D
timeFrame: 3 months and 6 months
measure: Delirium Free Days
timeFrame: Up to 30 Days
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hôpital du Sacré-Coeur de Montréal
state: Quebec
city: Montréal
country: Canada
facility: Centre hospitalier de l'Université de Montréal
state: Quebec
city: Quebec City
country: Canada
facility: L'Hôpital de l'Enfant-Jésus
state: Quebec
Study officials:
affiliation: Toronto General Hospital
name: Niall Ferguson, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Damon Scales, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: