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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
Extubation
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, Spontaneous intracerebral hemorrhage, Global cerebral anoxia/cardiac arrest, Meningitis/Encephalitis/Cerebral abscess, Seizure, Traumatic Brain Injury (TBI), Ischemic Stroke, Brain tumor

Eligibility Criteria

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

Inclusion Criteria:

  • Age > 16 years
  • Acute brain injury (subarachnoid hemorrhage, ischemic stroke, spontaneous intracerebral hemorrhage, seizure, traumatic brain injury, brain tumor, global cerebral anoxia/cardiac arrest, meningitis/encephalitis/cerebral abscess) that occurred within the previous 4 weeks.
  • Receiving invasive mechanical ventilation via endotracheal tube for > 72 hours
  • Glasgow Coma Scale motor score 3 to 6 with improvement or no change from previous day
  • passed spontaneous breathing trial (SBT)

Exclusion Criteria:

  • Previous extubation during this ICU admission
  • 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 expected mortality less than 6-months.
  • Anticipated/scheduled for surgical procedures within 48 hours
  • C-spine not yet cleared for activity as tolerated (cleared for activity as tolerated while wearing hard collar is acceptable)
  • Currently known or suspected to have an difficult airway
  • Absence of an endotracheal tube cuff leak, if checked
  • Absence of spontaneous or induced cough
  • Current enrolment in an RCT that precludes NEURO-ETT co-enrollment

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Extubation

Usual care

Arm Description

Extubation by removal of endotracheal tube.

The usual clinical practice is removal of the endotracheal tube (extubation), or insertion of tracheostomy, timed according to physicians' discretion

Outcomes

Primary Outcome Measures

ICU Free Days
The primary outcome is number of ICU free days to day 60, defined as the number of days spent alive and outside of an ICU until day 60. The primary outcome will be measured to answer the following primary question: Among patients receiving minimal mechanical ventilatory support for severe and persistent brain injury, which of the following airway management strategies increase ICU-free days to day 60: (1) prompt extubation vs. (2) usual care, which may include extubation or tracheostomy timed according to physicians' discretion?

Secondary Outcome Measures

Mortality,
Mortality at ICU discharge, mortality at hospital discharge, mortality at 3 months, mortality at 6 months
Ventilator-Free Days
Days free of mechanical ventilation, total duration (days) of ventilation among survivors
Airway Complications
Presence versus absence of airway complication
Nutrition Intake
Time to normal oral nutrition intake
Antibiotic Days
Injection or infusion of antibiotics given intravenously
Delirium
Presence versus absence of delirium experienced
Rate of Tracheostomy Insertion
Presence versus absence of tracheostomy insertion
Rate of ICU Readmission
ICU readmission rates to hospital discharge
Hospital Discharge Destination
Destination of the patient post hospitalization - home, rehabilitation facility, retirement home, long-term care/nursing home, no fixed address or shelter, continuing complex care, acute care hospital, other
Extended Glasgow Outcome Score
Functional outcome (scoring 1 to 8)
EQ-5D
Health related quality of life (scoring 1 to 5)

Full Information

First Posted
September 22, 2016
Last Updated
February 3, 2020
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT02920580
Brief Title
The NEUROlogically-impaired Extubation Timing Trial
Acronym
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
February 1, 2017 (Actual)
Primary Completion Date
June 19, 2019 (Actual)
Study Completion Date
January 31, 2022 (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 randomized controlled trial will enrol patients with acute severe brain injury who pass a spontaneous breathing trial but have decreased level of consciousness. It will directly compare (1) prompt extubation vs. (2) usual care, with extubation or tracheostomy timed according to physicians' discretion. The primary outcome will be ICU free days (days spent alive and outside an ICU).
Detailed Description
Thousands of patients suffer severe brain injuries every year, from causes such as trauma, stroke, and infection. Extensive clinical research in weaning from mechanical ventilation has led to recommendations for prompt extubation following a successful trial of spontaneous breathing in general intensive care unit (ICU). However, little evidence exists to guide decisions about when to remove the breathing tube in patients with severe brain injury. It is unclear which of the following strategies would optimize important patient outcomes: prompt extubation vs. waiting and extubating or performing a tracheostomy, timed according to physicians' discretion. Each strategy has associated risks: prompt extubation may lead to higher rates of extubation failure and reintubation, whereas waiting longer may expose patients to complications from prolonged mechanical ventilation and tracheostomy may lead to procedural complications (or unnecessary procedures, if prompt extubation would be successful). This trial in brain-injured patients will test which of the following will lead to better patient outcomes: (1) removing the endotracheal tube promptly once a spontaneous breathing trial is passed; or (2) usual care, with the airway management strategy selected according to the preference of the treating physician.

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, Spontaneous intracerebral hemorrhage, Global cerebral anoxia/cardiac arrest, Meningitis/Encephalitis/Cerebral abscess, Seizure, Traumatic Brain Injury (TBI), Ischemic Stroke, Brain tumor

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extubation
Arm Type
Active Comparator
Arm Description
Extubation by removal of endotracheal tube.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
The usual clinical practice is removal of the endotracheal tube (extubation), or insertion of tracheostomy, timed according to physicians' discretion
Intervention Type
Procedure
Intervention Name(s)
Extubation
Intervention Description
This is an extubation by removal of endotracheal tube which must be done on the day of randomization or the following day. Any decision to subsequently reintubate the patient will be left to the discretion of the clinical team. Similarly, if a tracheostomy is deemed necessary in a patient who fails the extubation attempt, this will be managed at the discretion of the treating team. If for any reason the patient is not extubated according to the randomized schedule, the reason(s) will be recorded on a protocol violation form and the site investigator will be notified. If a patient receives a tracheostomy instead of being extubated we will again record reasons for this, but the patient will be analysed in the extubation group according to the intention-to-treat principle.
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 (removal of endotracheal tube) or insertion of a tracheostomy, timed according to physicians' discretion. The inclusion of this arm will allow prompt extubation to be compared to usual practice, which often involves further observation and delayed decision-making due to clinician uncertainty about the optimal airway management strategy. Incorporation of usual care arms has been promoted as a design feature to improve the safety and interpretability of critical care clinical trials.
Primary Outcome Measure Information:
Title
ICU Free Days
Description
The primary outcome is number of ICU free days to day 60, defined as the number of days spent alive and outside of an ICU until day 60. The primary outcome will be measured to answer the following primary question: Among patients receiving minimal mechanical ventilatory support for severe and persistent brain injury, which of the following airway management strategies increase ICU-free days to day 60: (1) prompt extubation vs. (2) usual care, which may include extubation or tracheostomy timed according to physicians' discretion?
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Mortality,
Description
Mortality at ICU discharge, mortality at hospital discharge, mortality at 3 months, mortality at 6 months
Time Frame
up to 6 months
Title
Ventilator-Free Days
Description
Days free of mechanical ventilation, total duration (days) of ventilation among survivors
Time Frame
up to 60 days
Title
Airway Complications
Description
Presence versus absence of airway complication
Time Frame
up to 60 days
Title
Nutrition Intake
Description
Time to normal oral nutrition intake
Time Frame
up to 6 months
Title
Antibiotic Days
Description
Injection or infusion of antibiotics given intravenously
Time Frame
up to day 14
Title
Delirium
Description
Presence versus absence of delirium experienced
Time Frame
up to day 14
Title
Rate of Tracheostomy Insertion
Description
Presence versus absence of tracheostomy insertion
Time Frame
up to 6 months
Title
Rate of ICU Readmission
Description
ICU readmission rates to hospital discharge
Time Frame
up to hospital discharge
Title
Hospital Discharge Destination
Description
Destination of the patient post hospitalization - home, rehabilitation facility, retirement home, long-term care/nursing home, no fixed address or shelter, continuing complex care, acute care hospital, other
Time Frame
at hospital discharge
Title
Extended Glasgow Outcome Score
Description
Functional outcome (scoring 1 to 8)
Time Frame
up to 6 months
Title
EQ-5D
Description
Health related quality of life (scoring 1 to 5)
Time Frame
up to 6 months

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, ischemic stroke, spontaneous intracerebral hemorrhage, seizure, traumatic brain injury, brain tumor, global cerebral anoxia/cardiac arrest, meningitis/encephalitis/cerebral abscess) that occurred within the previous 4 weeks. Receiving invasive mechanical ventilation via endotracheal tube for > 72 hours Glasgow Coma Scale motor score 3 to 6 with improvement or no change from previous day passed spontaneous breathing trial (SBT) Exclusion Criteria: Previous extubation during this ICU admission 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 expected mortality less than 6-months. Anticipated/scheduled for surgical procedures within 48 hours C-spine not yet cleared for activity as tolerated (cleared for activity as tolerated while wearing hard collar is acceptable) Currently known or suspected to have an difficult airway Absence of an endotracheal tube cuff leak, if checked Absence of spontaneous or induced cough Current enrolment in an RCT that precludes NEURO-ETT co-enrollment
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 Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Centre hospitalier de l'Université de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2H8
Country
Canada
Facility Name
Hôpital du Sacré-Cœur de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
L'Hôpital de l'Enfant-Jésus
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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The NEUROlogically-impaired Extubation Timing Trial

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