The NEUROlogically-impaired Extubation Timing Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 332
- Locations
- 28
- Primary Endpoint
- Total Duration of Mechanical Ventilation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 16 years
- •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
- •Receiving mechanical ventilation via endotracheal tube for ≥ 48 hours
Exclusion Criteria
- •Quadriplegic
- •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
- •Do-Not-Reintubate order in place
- •Previously randomized in this trial
- •Underlying pre-existing condition with life expectancy less than 6-months
- •Current enrolment in an RCT that precludes NEURO-ETT co-enrollment
Outcomes
Primary Outcomes
Total Duration of Mechanical Ventilation
Time Frame: Up to 60 Days
Total duration of mechanical ventilation (to 60 days) accounting for the competing risk of death
Secondary Outcomes
- Mortality at ICU discharge and Hospital Discharge(ICU Discharge, Hospital Discharge, 3 months, and 6 months)
- ICU Free Days At Day 60(Up to 60 Days)
- Antibiotics Days(Up to 30 Days)
- Nutrition Intake(Up to 6 Months)
- Tracheostomy Rates(Up to 6 Months)
- Delirium Free Days(Up to 30 Days)
- Ventilator-Free Days at Day 60(Up to 60 days)
- Airway or Tracheostomy complications(Up to 30 days)
- Discharge Destination(Hospital discharge, up to 90 days)
- ICU Readmission Rates(Hospital discharge, up to 90 days)
- Extended Glasgow Outcome Score(3 months and 6 months)
- EuroQol-5D(3 months and 6 months)
Investigators
Dr. Damon Scales
Chief of Critical Care Medicine
Sunnybrook Health Sciences Centre