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

Not Applicable

• Conditions: Acute Brain Injury
• Interventions: Procedure: Usual Care; Procedure: Airway Management Pathway

• Registration Number: NCT04291235
• Lead Sponsor: Sunnybrook Health Sciences Centre

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 Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-27
• Last Update Submitted: 2020-02-27
• Study First Posted: 2020-03-02
• Last Update Posted: 2020-03-02
• Study Start: 2020-04-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 332

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	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
Airway Management Pathway	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 Free Days At Day 60	Up to 60 Days	ICU free days (days alive and not spent in an ICU)
Antibiotics Days	Up to 30 Days	Injection or infusion of antibiotics given intravenously
Nutrition Intake	Up to 6 Months	Time to normal oral nutrition intake
Tracheostomy Rates	Up to 6 Months	Presence versus absence of tracheostomy insertion
Delirium Free Days	Up to 30 Days	Days alive and free of delirium while in ICU up to day 30
Ventilator-Free Days at Day 60	Up to 60 days	Days alive and not receiving mechanical ventilation
Airway or Tracheostomy complications	Up to 30 days	Presence versus absence of airway complication
Discharge Destination	Hospital discharge, up to 90 days	Discharge destination for the patient post hospitalization
ICU Readmission Rates	Hospital discharge, up to 90 days	ICU readmission rates to hospital discharge
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

Trial Locations

Locations (14)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Nova Scotia Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

Centre hospitalier de l'Université de Montréal; 🇨🇦 Montréal, Quebec, Canada

Hôpital du Sacré-Coeur de Montréal; 🇨🇦 Montreal, Quebec, Canada

L'Hôpital de l'Enfant-Jésus; 🇨🇦 Quebec City, Quebec, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Royal Columbian Hospital; 🇨🇦 New Westminster, British Columbia, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada