Clinical Trial: The NEUROlogically-impaired Extubation Timing Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The NEUROlogically-impaired Extubation Timing Trial

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) 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).

Detailed Summary: 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.
Sponsor: Sunnybrook Health Sciences Centre

Current Primary Outcome: ICU Free Days [ Time Frame: 60 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Mortality, [ Time Frame: up to 6 months ]
  Mortality at ICU discharge, mortality at hospital discharge, mortality at 3 months, mortality at 6 months
• Ventilator-Free Days [ Time Frame: up to 60 days ]
  Days free of mechanical ventilation, total duration (days) of ventilation among survivors
• Airway Complications [ Time Frame: up to 60 days ]
  Presence versus absence of airway complication
• Nutrition Intake [ Time Frame: up to 6 months ]
  Time to normal oral nutrition intake
• Antibiotic Days [ Time Frame: up to day 14 ]
  Injection or infusion of antibiotics given intravenously
• ICU Delirium [ Time Frame: up to day 14 ]
  Presence versus absence of delirium experienced
• Rate of Tracheostomy Insertion [ Time Frame: up to 6 months ]
  Presence versus absence of tracheostomy insertion
• Rate of ICU Readmission [ Time Frame: up to hospital discharge ]
  ICU readmission rates to hospital discharge
• 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
• Extended Glasgow Outcome Score [ Time Frame: up to 6 months ]
  Functional outcome (scoring 1 to 8)
• EQ-5D [ Time Frame: up to 6 months ]
  Health related quality of life (scoring 1 to 5)

Original Secondary Outcome: Same as current

Information By: Sunnybrook Health Sciences Centre

Dates:
Date Received: September 22, 2016
Date Started: February 1, 2017
Date Completion: September 2021
Last Updated: February 3, 2017
Last Verified: September 2016