Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extubation | Active Comparator | Extubation by removal of endotracheal tube. |
|
| Usual care | Active Comparator | The usual clinical practice is removal of the endotracheal tube (extubation), or insertion of tracheostomy, timed according to physicians' discretion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality, | Mortality at ICU discharge, mortality at hospital discharge, mortality at 3 months, mortality at 6 months | up to 6 months |
| Ventilator-Free Days | Days free of mechanical ventilation, total duration (days) of ventilation among survivors |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Niall Ferguson, MD, MSc, | Toronto General Hospital | Principal Investigator |
| Damon Scales, MD, PhD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada | ||
| Royal Columbian Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D013345 | Subarachnoid Hemorrhage |
| D006323 | Heart Arrest |
| D008581 | Meningitis |
| D012640 | Seizures |
| D000070642 | Brain Injuries, Traumatic |
| D000083242 | Ischemic Stroke |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
Not provided
Not provided
| ID | Term |
|---|---|
| D060666 | Airway Extubation |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| up to 60 days |
| Airway Complications | Presence versus absence of airway complication | up to 60 days |
| Nutrition Intake | Time to normal oral nutrition intake | up to 6 months |
| Antibiotic Days | Injection or infusion of antibiotics given intravenously | up to day 14 |
| Delirium | Presence versus absence of delirium experienced | up to day 14 |
| Rate of Tracheostomy Insertion | Presence versus absence of tracheostomy insertion | up to 6 months |
| Rate of ICU Readmission | ICU readmission rates to hospital discharge | up to hospital discharge |
| 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 |
| Extended Glasgow Outcome Score | Functional outcome (scoring 1 to 8) | up to 6 months |
| EQ-5D | Health related quality of life (scoring 1 to 5) | up to 6 months |
| New Westminster |
| British Columbia |
| V3L 3W7 |
| Canada |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Hamilton General Hospital | Hamilton | Ontario | L8N 3Z5 | Canada |
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Toronto Western Hospital | Toronto | Ontario | M5G 2N2 | Canada |
| Centre hospitalier de l'Université de Montréal | Montreal | Quebec | H2X 2H8 | Canada |
| Hôpital du Sacré-Cœur de Montréal | Montreal | Quebec | H4J 1C5 | Canada |
| L'Hôpital de l'Enfant-Jésus | Québec | Quebec | G1J 1Z4 | Canada |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D020521 | Stroke |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |