NCT04291235

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

The NEUROlogically-impaired Extubation Timing Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 332 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This trial in brain-injured patients will test which of the following will lead to better patient outcomes: (1) an airway management pathway consisting of daily assessments and removal of the breathing tube as soon as patients can breathe on their own and appear able to protect their airway; versus (2) the usual treatment patients would have received if they were not enrolled in this trial.

Detailed description

Thousands of patients suffer severe brain injuries every year, from causes such as trauma, stroke, and infection. These patients are usually not fully awake and need help with their breathing and with preventing them from choking on their secretions. This is done with a breathing tube inserted through the mouth into the lungs and connected to a breathing machine. As patients recover, It is often unclear when the best time is to remove the breathing tube. Doctors might decide to remove it relatively early, or they may wait until the patient is more fully awake, or they may perform a tracheostomy (neck surgery to insert a new tube directly into the windpipe (trachea), replacing the temporary breathing tube). Each of these approaches has risks and benefits. This trial in brain-injured patients will test which of the following will lead to better patient outcomes: (1) an airway management pathway consisting of daily assessments and removal of the breathing tube as soon as patients can breathe on their own and appear able to protect their airway; versus (2) the usual treatment patients would have received if they were not enrolled in this trial.

Conditions

• Acute Brain Injury

Interventions

Type	Name	Description
PROCEDURE	Airway Management Pathway	Patients in this group will receive several components that comprise airway management pathway: (1) daily spontaneous breathing trials (SBTs); (2) prompt extubation following successful extubation readiness criteria; (3) high-flow nasal oxygen for at least 24 hours following extubation.
PROCEDURE	Usual Care	Patients in this group will be treated according to usual care, which may include extubation or tracheostomy timed according to treating physicians' discretion.

Timeline

• Start date: 2020-04-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2020-03-02
• Last updated: 2020-03-02

Locations

14 sites across 1 country: Canada