The NEUROlogically-impaired Extubation Timing Trial

Acute Brain Injury Clinical Trial

— NEURO-ETT  

Official title:

The NEUROlogically-impaired Extubation Timing Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02920580
• Other study ID #: NEURO-ETT (Vanguard)
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2020
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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) 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 27
• Est. completion date: January 31, 2022
• Est. primary completion date: June 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Brain Injury
• Brain Injuries

Intervention

Procedure:
• Extubation
This is an extubation by removal of endotracheal tube which must be done on the day of randomization or the following day. Any decision to subsequently reintubate the patient will be left to the discretion of the clinical team. Similarly, if a tracheostomy is deemed necessary in a patient who fails the extubation attempt, this will be managed at the discretion of the treating team. If for any reason the patient is not extubated according to the randomized schedule, the reason(s) will be recorded on a protocol violation form and the site investigator will be notified. If a patient receives a tracheostomy instead of being extubated we will again record reasons for this, but the patient will be analysed in the extubation group according to the intention-to-treat principle.
• Usual Care
Patients in this group will be treated according to usual care, which may include extubation (removal of endotracheal tube) or insertion of a tracheostomy, timed according to physicians' discretion. The inclusion of this arm will allow prompt extubation to be compared to usual practice, which often involves further observation and delayed decision-making due to clinician uncertainty about the optimal airway management strategy. Incorporation of usual care arms has been promoted as a design feature to improve the safety and interpretability of critical care clinical trials.

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Centre hospitalier de l'Université de Montréal	Montreal	Quebec
Canada	Hôpital du Sacré-Cœur de Montréal	Montreal	Quebec
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	Ottawa Hospital	Ottawa	Ontario
Canada	L'Hôpital de l'Enfant-Jésus	Quebec City	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

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