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

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ClinicalTrials.gov Identifier: NCT02920580
Recruitment Status : Recruiting
First Posted : September 30, 2016
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Damon Scales, Sunnybrook Health Sciences Centre

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).

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 410 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The NEUROlogically-impaired Extubation Timing Trial
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Active Comparator: Extubation
Extubation by removal of endotracheal tube.
Procedure: Extubation
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.

Active Comparator: Usual care
The usual clinical practice is removal of the endotracheal tube (extubation), or insertion of tracheostomy, timed according to physicians' discretion
Procedure: Usual Care
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 Measures :
  1. ICU Free Days [ Time Frame: 60 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 :
  1. Mortality, [ Time Frame: up to 6 months ]
    Mortality at ICU discharge, mortality at hospital discharge, mortality at 3 months, mortality at 6 months

  2. Ventilator-Free Days [ Time Frame: up to 60 days ]
    Days free of mechanical ventilation, total duration (days) of ventilation among survivors

  3. Airway Complications [ Time Frame: up to 60 days ]
    Presence versus absence of airway complication

  4. Nutrition Intake [ Time Frame: up to 6 months ]
    Time to normal oral nutrition intake

  5. Antibiotic Days [ Time Frame: up to day 14 ]
    Injection or infusion of antibiotics given intravenously

  6. Delirium [ Time Frame: up to day 14 ]
    Presence versus absence of delirium experienced

  7. Rate of Tracheostomy Insertion [ Time Frame: up to 6 months ]
    Presence versus absence of tracheostomy insertion

  8. Rate of ICU Readmission [ Time Frame: up to hospital discharge ]
    ICU readmission rates to hospital discharge

  9. Hospital Discharge Destination [ Time Frame: at hospital discharge ]
    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

  10. Extended Glasgow Outcome Score [ Time Frame: up to 6 months ]
    Functional outcome (scoring 1 to 8)

  11. EQ-5D [ Time Frame: up to 6 months ]
    Health related quality of life (scoring 1 to 5)



Information from the National Library of Medicine

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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:

  • 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

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): NCT02920580


Contacts
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Contact: Venika Manoharan, HBSc 4164806100 ext 88136 venika.manoharan@sunnybrook.ca

Locations
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Canada, Alberta
University of Alberta Hospital Not yet recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: David Zygun, MD    780-492-8597    zygun@ualberta.ca   
Canada, British Columbia
Royal Columbian Hospital Not yet recruiting
New Westminster, British Columbia, Canada, V3L 3W7
Contact: Steven Reynolds, MD       steven.reynolds@fraserhealth.ca   
Vancouver General Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Donald Griesdale, MD    604-875-4304    Donald.Griesdale@vch.ca   
Canada, Ontario
Hamilton General Hospital Not yet recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Sunjay Sharma, MD    905-521-2100 ext 44721    sharmasun@hhsc.ca   
Kingston General Hospital Not yet recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: J. Gordon Boyd, MD    613-549-6666 ext 6228    2jgb1@queensu.ca   
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A 5A5
Contact: Karen Bosma, MD    519-663-3531    Karenj.Bosma@lhsc.on.ca   
Ottawa Hospital Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Shane English, MD    613-737-8726    senglish@ohri.ca   
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Damon Scales, MD    416-480-6100 ext 5291    damon.scales@sunnybrook.ca   
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Andrew Baker, MD    416-864-5559    bakera@smh.ca   
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Jeff Singh, MD    416-603-5800 ext 3221    Jeff.Singh@uhn.ca   
Canada, Quebec
Centre hospitalier de l'Université de Montréal Not yet recruiting
Montreal, Quebec, Canada, H2X 2H8
Contact: Michaël Chassé, MD    514-890-8000 ext 30816    michael.chasse.chum@ssss.gouv.qc.ca   
Hôpital du Sacré-Cœur de Montréal Not yet recruiting
Montreal, Quebec, Canada, H4J 1C5
Contact: Emmanuel Charbonney, MD    514 338 2050    emmanuel.charbonney@umontreal.ca   
L'Hôpital de l'Enfant-Jésus Not yet recruiting
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: Damon Scales, MD, PhD Sunnybrook Health Sciences Centre

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Responsible Party: Dr. Damon Scales, MD, PhD, FRCPC, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02920580     History of Changes
Other Study ID Numbers: NEURO-ETT
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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