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

Sunnybrook Health Sciences Centre

Status

Unknown

Conditions

Acute Brain Injury

Treatments

Procedure: Usual Care

Procedure: Extubation

Study type

Interventional

Funder types

Other

Identifiers

NCT02920580

NEURO-ETT (Vanguard)

Details and patient eligibility

About

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).

Full 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.

Enrollment

27 patients

Sex

All

Ages

16+ years old

Volunteers

No 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