The NEUROlogically-impaired Extubation Timing Trial (NCT02920580) | Clinical Trial Compass
UnknownNot Applicable
The NEUROlogically-impaired Extubation Timing Trial
Canada27 participantsStarted 2017-02-01
Plain-language 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).
Who can participate
Age range16 Years
SexALL
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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