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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04291235
Recruitment Status : Not yet recruiting
First Posted : March 2, 2020
Last Update Posted : March 2, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Damon Scales, 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.

Condition or disease Intervention/treatment Phase
Acute Brain Injury Procedure: Airway Management Pathway Procedure: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The NEUROlogically-impaired Extubation Timing Trial
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Total Duration of Mechanical Ventilation [ Time Frame: Up to 60 Days ]
    Total duration of mechanical ventilation (to 60 days) accounting for the competing risk of death


Secondary Outcome Measures :
  1. Mortality at ICU discharge and Hospital Discharge [ Time Frame: ICU Discharge, Hospital Discharge, 3 months, and 6 months ]
    Mortality at ICU Discharge, Hospital Discharge, 3 months, and 6 months

  2. Ventilator-Free Days at Day 60 [ Time Frame: Up to 60 days ]
    Days alive and not receiving mechanical ventilation

  3. ICU Free Days At Day 60 [ Time Frame: Up to 60 Days ]
    ICU free days (days alive and not spent in an ICU)

  4. Airway or Tracheostomy complications [ Time Frame: Up to 30 days ]
    Presence versus absence of airway complication

  5. Nutrition Intake [ Time Frame: Up to 6 Months ]
    Time to normal oral nutrition intake

  6. Antibiotics Days [ Time Frame: Up to 30 Days ]
    Injection or infusion of antibiotics given intravenously

  7. Tracheostomy Rates [ Time Frame: Up to 6 Months ]
    Presence versus absence of tracheostomy insertion

  8. ICU Readmission Rates [ Time Frame: Hospital discharge, up to 90 days ]
    ICU readmission rates to hospital discharge

  9. Discharge Destination [ Time Frame: Hospital discharge, up to 90 days ]
    Discharge destination for the patient post hospitalization

  10. Extended Glasgow Outcome Score [ Time Frame: 3 months and 6 months ]
    Minimum score 1 (worst) to maximum score 8 (best) at 3 months and 6 months

  11. EuroQol-5D [ Time Frame: 3 months and 6 months ]
    Minimum score 1 (worst) to maximum score 100 (best) at 3 months and 6 months

  12. Delirium Free Days [ Time Frame: Up to 30 Days ]
    Days alive and free of delirium while in ICU up to day 30



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04291235


Contacts
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Contact: Venika Manoharan, HBSc 416-480-6100 ext 88136 venika.manoharan@sunnybrook.ca

Locations
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Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Contact: David Zygun, MD    780-492-8597    zygun@ualberta.ca   
Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Contact: Steven Reynolds, MD       steven.reynolds@fraserhealth.ca   
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Donald Griesdale, MD    604-875-4304    Donald.Griesdale@vch.ca   
Canada, Nova Scotia
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Laurel Murphey, MD    902-473-3486    laurel.murphy@nshealth.ca   
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Sunjay Sharma, MD    905-521-2100 ext 44721    sharmasun@hhsc.ca   
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Contact: J. Gordon Boyd, MD    613-549-6666 ext 6228    2jgb1@queensu.ca   
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Contact: Karen Bosma, MD    519-663-3531    Karenj.Bosma@lhsc.on.ca   
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Contact: Shane English, MD    613-737-8726    senglish@ohri.ca   
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Contact: Damon Scales, MD    416-480-6100 ext 5291    damon.scales@sunnybrook.ca   
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Contact: Andrew Baker, MD    416-864-5559    bakera@smh.ca   
Toronto Western Hospital
Toronto, Ontario, Canada, M5G 2N2
Contact: Jeff Singh, MD    416-603-5800 ext 3221    Jeff.Singh@uhn.ca   
Canada, Quebec
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, Canada, H4J 1C5
Contact: Emmanuel Charbonney, MD    514 338 2050    emmanuel.charbonney@umontreal.ca   
Centre hospitalier de l'Université de Montréal
Montréal, Quebec, Canada, H2X 2H8
Contact: Michaël Chassé, MD    514-890-8000 ext 30816    michael.chasse.chum@ssss.gouv.qc.ca   
L'Hôpital de l'Enfant-Jésus
Quebec City, Quebec, Canada, G1J 1Z4
Contact: Alexis Turgeon, MD    418-649-0252 ext 66064    alexis.turgeon@fmed.ulaval.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Niall Ferguson, MD, MSc Toronto General Hospital
Principal Investigator: Damon Scales, MD, PhD Sunnybrook Health Sciences Centre
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Responsible Party: Dr. Damon Scales, Chief of Critical Care Medicine, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04291235    
Other Study ID Numbers: NEURO-ETT
First Posted: March 2, 2020    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Damon Scales, Sunnybrook Health Sciences Centre:
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
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries