Acute Brain Injury
Conditions
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
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.
Interventions
PROCEDUREAirway 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.
PROCEDUREUsual Care
Patients in this group will be treated according to usual care, which may include extubation or tracheostomy timed according to treating physicians' discretion.
Sponsors
Canadian Institutes of Health Research (CIHR)
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Duration of Mechanical Ventilation | Up to 60 Days | Total duration of mechanical ventilation (to 60 days) accounting for the competing risk of death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-Free Days at Day 60 | Up to 60 days | Days alive and not receiving mechanical ventilation |
| ICU Free Days At Day 60 | Up to 60 Days | ICU free days (days alive and not spent in an ICU) |
| Airway or Tracheostomy complications | Up to 30 days | Presence versus absence of airway complication |
| Nutrition Intake | Up to 6 Months | Time to normal oral nutrition intake |
| Antibiotics Days | Up to 30 Days | Injection or infusion of antibiotics given intravenously |
| Mortality at ICU discharge and Hospital Discharge | ICU Discharge, Hospital Discharge, 3 months, and 6 months | Mortality at ICU Discharge, Hospital Discharge, 3 months, and 6 months |
| ICU Readmission Rates | Hospital discharge, up to 90 days | ICU readmission rates to hospital discharge |
| Discharge Destination | Hospital discharge, up to 90 days | Discharge destination for the patient post hospitalization |
| Extended Glasgow Outcome Score | 3 months and 6 months | Minimum score 1 (worst) to maximum score 8 (best) at 3 months and 6 months |
| EuroQol-5D | 3 months and 6 months | Minimum score 1 (worst) to maximum score 100 (best) at 3 months and 6 months |
| Delirium Free Days | Up to 30 Days | Days alive and free of delirium while in ICU up to day 30 |
| Tracheostomy Rates | Up to 6 Months | Presence versus absence of tracheostomy insertion |
Countries
Canada
Contacts
Primary ContactVenika Manoharan, HBSc
Outcome results
None listed