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

Acute Brain Injury Clinical Trial

Official title:

The NEUROlogically-impaired Extubation Timing Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04291235
• Other study ID #: NEURO-ETT
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: February 2020
• Source: Sunnybrook Health Sciences Centre
• Contact: Venika Manoharan, HBSc
• Phone: 416-480-6100
• Email: venika.manoharan[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 332
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Brain Injury
• Brain Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Hôpital du Sacré-Coeur de Montréal	Montreal	Quebec
Canada	Centre hospitalier de l'Université de Montréal	Montréal	Quebec
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	Ottawa Hospital	Ottawa	Ontario
Canada	L'Hôpital de l'Enfant-Jésus	Quebec City	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

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