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

Overview

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.

Full Title of Study: “The NEUROlogically-impaired Extubation Timing Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 1, 2023

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

  • Procedure: Airway 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.
  • Procedure: Usual Care
    • Patients in this group will be treated according to usual care, which may include extubation or tracheostomy timed according to treating physicians’ discretion.

Arms, Groups and Cohorts

  • Active Comparator: Airway Management Pathway
    • 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
  • Active Comparator: Usual Care
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Mortality at ICU discharge and Hospital Discharge
    • Time Frame: ICU Discharge, Hospital Discharge, 3 months, and 6 months
    • Mortality at ICU Discharge, Hospital Discharge, 3 months, and 6 months
  • Ventilator-Free Days at Day 60
    • Time Frame: Up to 60 days
    • Days alive and not receiving mechanical ventilation
  • ICU Free Days At Day 60
    • Time Frame: Up to 60 Days
    • ICU free days (days alive and not spent in an ICU)
  • Airway or Tracheostomy complications
    • Time Frame: Up to 30 days
    • Presence versus absence of airway complication
  • Nutrition Intake
    • Time Frame: Up to 6 Months
    • Time to normal oral nutrition intake
  • Antibiotics Days
    • Time Frame: Up to 30 Days
    • Injection or infusion of antibiotics given intravenously
  • Tracheostomy Rates
    • Time Frame: Up to 6 Months
    • Presence versus absence of tracheostomy insertion
  • ICU Readmission Rates
    • Time Frame: Hospital discharge, up to 90 days
    • ICU readmission rates to hospital discharge
  • Discharge Destination
    • Time Frame: Hospital discharge, up to 90 days
    • Discharge destination for the patient post hospitalization
  • Extended Glasgow Outcome Score
    • Time Frame: 3 months and 6 months
    • Minimum score 1 (worst) to maximum score 8 (best) at 3 months and 6 months
  • EuroQol-5D
    • Time Frame: 3 months and 6 months
    • Minimum score 1 (worst) to maximum score 100 (best) at 3 months and 6 months
  • Delirium Free Days
    • Time Frame: Up to 30 Days
    • Days alive and free of delirium while in ICU up to day 30

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sunnybrook Health Sciences Centre
  • Collaborator
    • Canadian Institutes of Health Research (CIHR)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Damon Scales, Chief of Critical Care Medicine – Sunnybrook Health Sciences Centre
  • Overall Official(s)
    • Niall Ferguson, MD, MSc, Principal Investigator, Toronto General Hospital
    • Damon Scales, MD, PhD, Principal Investigator, Sunnybrook Health Sciences Centre
  • Overall Contact(s)
    • Venika Manoharan, HBSc, 416-480-6100, venika.manoharan@sunnybrook.ca

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