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

Primary Purpose

Acute Brain Injury

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Airway Management Pathway
Usual Care
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Brain Injury focused on measuring 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

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alberta Hospital
  • Royal Columbian Hospital
  • Vancouver General Hospital
  • Nova Scotia Health Authority
  • Hamilton General Hospital
  • Kingston General Hospital
  • London Health Sciences Centre
  • Ottawa Hospital
  • Sunnybrook Health Sciences Centre
  • St. Michael's Hospital
  • Toronto Western Hospital
  • Hôpital du Sacré-Coeur de Montréal
  • Centre hospitalier de l'Université de Montréal
  • L'Hôpital de l'Enfant-Jésus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Airway Management Pathway

Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Total Duration of Mechanical Ventilation
Total duration of mechanical ventilation (to 60 days) accounting for the competing risk of death

Secondary Outcome Measures

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

Full Information

First Posted
February 3, 2020
Last Updated
February 27, 2020
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT04291235
Brief Title
The NEUROlogically-impaired Extubation Timing Trial (NEURO-ETT)
Official Title
The NEUROlogically-impaired Extubation Timing Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Brain Injury
Keywords
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
332 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Airway Management Pathway
Arm Type
Active Comparator
Arm Description
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
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Airway Management Pathway
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Usual Care
Intervention Description
Patients in this group will be treated according to usual care, which may include extubation or tracheostomy timed according to treating physicians' discretion.
Primary Outcome Measure Information:
Title
Total Duration of Mechanical Ventilation
Description
Total duration of mechanical ventilation (to 60 days) accounting for the competing risk of death
Time Frame
Up to 60 Days
Secondary Outcome Measure Information:
Title
Mortality at ICU discharge and Hospital Discharge
Description
Mortality at ICU Discharge, Hospital Discharge, 3 months, and 6 months
Time Frame
ICU Discharge, Hospital Discharge, 3 months, and 6 months
Title
Ventilator-Free Days at Day 60
Description
Days alive and not receiving mechanical ventilation
Time Frame
Up to 60 days
Title
ICU Free Days At Day 60
Description
ICU free days (days alive and not spent in an ICU)
Time Frame
Up to 60 Days
Title
Airway or Tracheostomy complications
Description
Presence versus absence of airway complication
Time Frame
Up to 30 days
Title
Nutrition Intake
Description
Time to normal oral nutrition intake
Time Frame
Up to 6 Months
Title
Antibiotics Days
Description
Injection or infusion of antibiotics given intravenously
Time Frame
Up to 30 Days
Title
Tracheostomy Rates
Description
Presence versus absence of tracheostomy insertion
Time Frame
Up to 6 Months
Title
ICU Readmission Rates
Description
ICU readmission rates to hospital discharge
Time Frame
Hospital discharge, up to 90 days
Title
Discharge Destination
Description
Discharge destination for the patient post hospitalization
Time Frame
Hospital discharge, up to 90 days
Title
Extended Glasgow Outcome Score
Description
Minimum score 1 (worst) to maximum score 8 (best) at 3 months and 6 months
Time Frame
3 months and 6 months
Title
EuroQol-5D
Description
Minimum score 1 (worst) to maximum score 100 (best) at 3 months and 6 months
Time Frame
3 months and 6 months
Title
Delirium Free Days
Description
Days alive and free of delirium while in ICU up to day 30
Time Frame
Up to 30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Venika Manoharan, HBSc
Phone
416-480-6100
Ext
88136
Email
venika.manoharan@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niall Ferguson, MD, MSc
Organizational Affiliation
Toronto General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Damon Scales, MD, PhD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Zygun, MD
Phone
780-492-8597
Email
zygun@ualberta.ca
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Reynolds, MD
Email
steven.reynolds@fraserhealth.ca
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donald Griesdale, MD
Phone
604-875-4304
Email
Donald.Griesdale@vch.ca
Facility Name
Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurel Murphey, MD
Phone
902-473-3486
Email
laurel.murphy@nshealth.ca
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunjay Sharma, MD
Phone
905-521-2100
Ext
44721
Email
sharmasun@hhsc.ca
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Gordon Boyd, MD
Phone
613-549-6666
Ext
6228
Email
2jgb1@queensu.ca
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Bosma, MD
Phone
519-663-3531
Email
Karenj.Bosma@lhsc.on.ca
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shane English, MD
Phone
613-737-8726
Email
senglish@ohri.ca
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damon Scales, MD
Phone
416-480-6100
Ext
5291
Email
damon.scales@sunnybrook.ca
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Baker, MD
Phone
416-864-5559
Email
bakera@smh.ca
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff Singh, MD
Phone
416-603-5800
Ext
3221
Email
Jeff.Singh@uhn.ca
Facility Name
Hôpital du Sacré-Coeur de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel Charbonney, MD
Phone
514 338 2050
Email
emmanuel.charbonney@umontreal.ca
Facility Name
Centre hospitalier de l'Université de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 2H8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michaël Chassé, MD
Phone
514-890-8000
Ext
30816
Email
michael.chasse.chum@ssss.gouv.qc.ca
Facility Name
L'Hôpital de l'Enfant-Jésus
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis Turgeon, MD
Phone
418-649-0252
Ext
66064
Email
alexis.turgeon@fmed.ulaval.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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

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