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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
332
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.
Patients in this group will be treated according to usual care, which may include extubation or tracheostomy timed according to treating physicians' discretion.
University of Alberta Hospital
Edmonton, Alberta, Canada
Royal Columbian Hospital
New Westminster, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Total Duration of Mechanical Ventilation
Total duration of mechanical ventilation (to 60 days) accounting for the competing risk of death
Time frame: Up to 60 Days
Mortality at ICU discharge and Hospital Discharge
Mortality at ICU Discharge, Hospital Discharge, 3 months, and 6 months
Time frame: ICU Discharge, Hospital Discharge, 3 months, and 6 months
Ventilator-Free Days at Day 60
Days alive and not receiving mechanical ventilation
Time frame: Up to 60 days
ICU Free Days At Day 60
ICU free days (days alive and not spent in an ICU)
Time frame: Up to 60 Days
Airway or Tracheostomy complications
Presence versus absence of airway complication
Time frame: Up to 30 days
Nutrition Intake
Time to normal oral nutrition intake
Time frame: Up to 6 Months
Antibiotics Days
Injection or infusion of antibiotics given intravenously
Time frame: Up to 30 Days
Tracheostomy Rates
Presence versus absence of tracheostomy insertion
Time frame: Up to 6 Months
ICU Readmission Rates
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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
...and 4 more locations
ICU readmission rates to hospital discharge
Time frame: Hospital discharge, up to 90 days
Discharge Destination
Discharge destination for the patient post hospitalization
Time frame: Hospital discharge, up to 90 days
Extended Glasgow Outcome Score
Minimum score 1 (worst) to maximum score 8 (best) at 3 months and 6 months
Time frame: 3 months and 6 months
EuroQol-5D
Minimum score 1 (worst) to maximum score 100 (best) at 3 months and 6 months
Time frame: 3 months and 6 months
Delirium Free Days
Days alive and free of delirium while in ICU up to day 30
Time frame: Up to 30 Days