Clinical trial NCT02920580: The NEUROlogically-impaired Extubation Timing Trial
Official title: The NEUROlogically-impaired Extubation Timing Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2016-09-30
Enrollment: 27
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: ICU Free Days
timeFrame: 60 days
Secondary outcomes:
measure: Mortality,
timeFrame: up to 6 months
measure: Ventilator-Free Days
timeFrame: up to 60 days
measure: Airway Complications
timeFrame: up to 60 days
measure: Nutrition Intake
timeFrame: up to 6 months
measure: Antibiotic Days
timeFrame: up to day 14
measure: Delirium
timeFrame: up to day 14
measure: Rate of Tracheostomy Insertion
timeFrame: up to 6 months
measure: Rate of ICU Readmission
timeFrame: up to hospital discharge
measure: Hospital Discharge Destination
timeFrame: at hospital discharge
measure: Extended Glasgow Outcome Score
timeFrame: up to 6 months
measure: EQ-5D
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre hospitalier de l'Université de Montréal
state: Quebec
city: Montreal
country: Canada
facility: Hôpital du Sacré-Cœur de Montréal
state: Quebec
city: Quebec City
country: Canada
facility: L'Hôpital de l'Enfant-Jésus
state: Quebec
Study officials:
affiliation: Toronto General Hospital
name: Niall Ferguson, MD, MSc,
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Damon Scales, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: