The NEUROlogically-impaired Extubation Timing Trial

NCT02920580 | Unknown DMC

• 1 other identifier: NEURO-ETT (Vanguard)
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 13

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).

Conditions

Acute Brain Injury

Keywords

Subarachnoid hemorrhage; Spontaneous intracerebral hemorrhage; Global cerebral anoxia/cardiac arrest; Meningitis/Encephalitis/Cerebral abscess; Seizure; Traumatic Brain Injury (TBI); Ischemic Stroke; Brain tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Mortality,

  up to 6 months

• Ventilator-Free Days

  up to 60 days

• Airway Complications

  up to 60 days

• Nutrition Intake

  up to 6 months

• Antibiotic Days

  up to day 14

Study Arms (2)

Extubation

ACTIVE COMPARATOR

Extubation by removal of endotracheal tube.

Procedure: Extubation

Usual care

ACTIVE COMPARATOR

The usual clinical practice is removal of the endotracheal tube (extubation), or insertion of tracheostomy, timed according to physicians' discretion

Procedure: Usual Care

Interventions

Extubation PROCEDURE

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.

Extubation

Usual Care PROCEDURE

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.

Usual care

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (13)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 2H8, Canada

Location

Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

L'Hôpital de l'Enfant-Jésus

Québec, Quebec, G1J 1Z4, Canada

Location

MeSH Terms

Conditions

Brain Injuries; Subarachnoid Hemorrhage; Heart Arrest; Meningitis; Seizures; Brain Injuries, Traumatic; Ischemic Stroke; Brain Neoplasms

Interventions

Airway Extubation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Neuroinflammatory Diseases; Neurologic Manifestations; Signs and Symptoms; Stroke; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Investigative Techniques

Study Officials

• Niall Ferguson, MD, MSc,

  Toronto General Hospital

  PRINCIPAL INVESTIGATOR

• Damon Scales, MD, PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FRCPC

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 30, 2016
• Study Start: February 1, 2017
• Primary Completion: June 19, 2019
• Study Completion: January 31, 2022
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (13)