The NEUROlogically-impaired Extubation Timing Trial (NEURO-ETT)

Study Overview
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Brief Summary
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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
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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.

Official Title
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The NEUROlogically-impaired Extubation Timing Trial

Conditions
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Acute Brain Injury

Intervention / Treatment
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* Procedure: Airway Management Pathway
* Procedure: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Airway Management Pathway<br>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 | Procedure: Airway Management Pathway<br>* 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.<br>|
| Active Comparator: Usual Care<br>The usual clinical practice is often to keep the patient on artificial respiration for longer in the hope that the patient will wake up before removing the tube, or performing a tracheostomy if the patient doesn't wake up | Procedure: Usual Care<br>* Patients in this group will be treated according to usual care, which may include extubation or tracheostomy timed according to treating physicians' discretion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Duration of Mechanical Ventilation | Total duration of mechanical ventilation (to 60 days) accounting for the competing risk of death | Up to 60 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at ICU discharge and Hospital Discharge | Mortality at ICU Discharge, Hospital Discharge, 3 months, and 6 months | ICU Discharge, Hospital Discharge, 3 months, and 6 months | 
| Ventilator-Free Days at Day 60 | Days alive and not receiving mechanical ventilation | Up to 60 days | 
| ICU Free Days At Day 60 | ICU free days (days alive and not spent in an ICU) | Up to 60 Days | 
| Airway or Tracheostomy complications | Presence versus absence of airway complication | Up to 30 days | 
| Nutrition Intake | Time to normal oral nutrition intake | Up to 6 Months | 
| Antibiotics Days | Injection or infusion of antibiotics given intravenously | Up to 30 Days | 
| Tracheostomy Rates | Presence versus absence of tracheostomy insertion | Up to 6 Months | 
| ICU Readmission Rates | ICU readmission rates to hospital discharge | Hospital discharge, up to 90 days | 
| Discharge Destination | Discharge destination for the patient post hospitalization | 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 | 3 months and 6 months | 
| EuroQol-5D | Minimum score 1 (worst) to maximum score 100 (best) at 3 months and 6 months | 3 months and 6 months | 
| Delirium Free Days | Days alive and free of delirium while in ICU up to day 30 | Up to 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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