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

The NEUROlogically-impaired Extubation Timing Trial

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 Overview

• Status: Unknown
• Conditions: Acute Brain Injury
• Intervention / Treatment: Procedure: Airway Management Pathway; Procedure: Usual Care

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 Type: Interventional
• Enrollment (Anticipated): 332
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W7
      • Royal Columbian Hospital
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Nova Scotia Health Authority
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Hamilton General Hospital
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston General Hospital
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
    • Toronto, Ontario, Canada, M5G 2N2
      • Toronto Western Hospital
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • Hopital Du Sacre-Coeur de Montreal
    • Montréal, Quebec, Canada, H2X 2H8
      • Centre Hospitalier de l'Université de Montréal
    • Quebec City, Quebec, Canada, G1J 1Z4
      • L'Hôpital de l'Enfant-Jésus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.
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	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Niall Ferguson, MD, MSc, Toronto General Hospital; Principal Investigator: Damon Scales, MD, PhD, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Brain Tumor; Subarachnoid Hemorrhage; Ischemic Stroke; Intracerebral Hemorrhage; Seizure; Subdural Hematoma; Diffuse Axonal Injury; Global Cerebral Anoxia/Cardiac Arrest; Meningitis/Encephalitis; Cerebral Abscess; Epidural Hematoma
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: NEURO-ETT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No