The NEUROlogically-impaired Extubation Timing Trial

Not Applicable

• Conditions: Acute Brain Injury
• Interventions: Procedure: Extubation; Procedure: Usual Care

• Registration Number: NCT02920580
• Lead Sponsor: Sunnybrook Health Sciences Centre

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) 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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-09-22
• Study First Submitted QC: 2016-09-28
• Study First Posted: 2016-09-30
• Study Start: 2017-02-01
• Primary Completion: 2019-06-19
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 27

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extubation	Extubation	Extubation by removal of endotracheal tube.
Usual care	Usual Care	The usual clinical practice is removal of the endotracheal tube (extubation), or insertion of tracheostomy, timed according to physicians' discretion

Primary Outcome Measures

Name	Time	Method
ICU Free Days	60 days	The primary outcome is number of ICU free days to day 60, defined as the number of days spent alive and outside of an ICU until day 60.; The primary outcome will be measured to answer the following primary question: Among patients receiving minimal mechanical ventilatory support for severe and persistent brain injury, which of the following airway management strategies increase ICU-free days to day 60: (1) prompt extubation vs. (2) usual care, which may include extubation or tracheostomy timed according to physicians' discretion?

Secondary Outcome Measures

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

Trial Locations

Locations (13)

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Centre hospitalier de l'Université de Montréal; 🇨🇦 Montreal, Quebec, Canada

L'Hôpital de l'Enfant-Jésus; 🇨🇦 Quebec City, Quebec, Canada

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Royal Columbian Hospital; 🇨🇦 New Westminster, British Columbia, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Hôpital du Sacré-Cœur de Montréal; 🇨🇦 Montreal, Quebec, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada