The NEUROlogically-impaired Extubation Timing Trial

Official Title

The NEUROlogically-impaired Extubation Timing Trial

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) prompt tracheostomy vs. (3) 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).

Trial Description

Primary Outcome:

  • ICU Free Days
Secondary Outcome:
  • Mortality,
  • Ventilator-Free Days
  • Airway Complications
  • Nutrition Intake
  • Antibiotic Days
  • ICU Delirium
  • Rate of Tracheostomy Insertion
  • Rate of ICU Readmission
  • Hospital Discharge Destination
  • Extended Glasgow Outcome Score
  • EQ-5D
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. prompt tracheostomy 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, prompt tracheostomy may lead to an excess of unnecessary procedures, and waiting longer may expose patients to complications from prolonged mechanical ventilation.This trial in brain-injured patients will test will of the following will lead to better patient outcomes: (1) removing the temporary breathing tube promptly; (2) performing a tracheostomy promptly; or (3) the usual treatment you would have received if you were not enrolled in this trial.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society