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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Airway Management Pathway | Active Comparator | 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 |
|
| Usual Care | Active Comparator | The usual clinical practice is often to keep the patient on artificial respiration for longer in the hope that the patient will wake up before removing the tube, or performing a tracheostomy if the patient doesn't wake up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Airway Management Pathway | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Duration of Mechanical Ventilation | Total duration of mechanical ventilation (to 60 days) accounting for the competing risk of death | Up to 60 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at ICU discharge and Hospital Discharge | Mortality at ICU Discharge, Hospital Discharge, 3 months, and 6 months | ICU Discharge, Hospital Discharge, 3 months, and 6 months |
| Ventilator-Free Days at Day 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Venika Manoharan, HBSc | Contact | 416-480-6100 | 88136 | venika.manoharan@sunnybrook.ca |
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39585965 | Derived | Angriman F, Amaral ACKB, Fan E, Taran S, McCredie VA, Baker A, Bosma KJ, Brochard LJ, Adhikari NKJ, Cuthbertson BH, Scales DC, Ferguson ND. Timing of Extubation in Adult Patients with Acute Brain Injury. Am J Respir Crit Care Med. 2025 Mar;211(3):339-346. doi: 10.1164/rccm.202408-1553OC. |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D013345 | Subarachnoid Hemorrhage |
| D020833 | Diffuse Axonal Injury |
| D000083242 | Ischemic Stroke |
| D002543 | Cerebral Hemorrhage |
| D001932 | Brain Neoplasms |
| D006323 | Heart Arrest |
| D008581 | Meningitis |
| D004660 | Encephalitis |
| D001922 | Brain Abscess |
| D046748 | Hematoma, Epidural, Spinal |
| D006408 | Hematoma, Subdural |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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|
| Usual Care | Procedure | Patients in this group will be treated according to usual care, which may include extubation or tracheostomy timed according to treating physicians' discretion. |
|
Days alive and not receiving mechanical ventilation
| Up to 60 days |
| ICU Free Days At Day 60 | ICU free days (days alive and not spent in an ICU) | Up to 60 Days |
| Airway or Tracheostomy complications | Presence versus absence of airway complication | Up to 30 days |
| Nutrition Intake | Time to normal oral nutrition intake | Up to 6 Months |
| Antibiotics Days | Injection or infusion of antibiotics given intravenously | Up to 30 Days |
| Tracheostomy Rates | Presence versus absence of tracheostomy insertion | Up to 6 Months |
| ICU Readmission Rates | ICU readmission rates to hospital discharge | Hospital discharge, up to 90 days |
| Discharge Destination | Discharge destination for the patient post hospitalization | Hospital discharge, up to 90 days |
| Extended Glasgow Outcome Score | Minimum score 1 (worst) to maximum score 8 (best) at 3 months and 6 months | 3 months and 6 months |
| EuroQol-5D | Minimum score 1 (worst) to maximum score 100 (best) at 3 months and 6 months | 3 months and 6 months |
| Delirium Free Days | Days alive and free of delirium while in ICU up to day 30 | Up to 30 Days |
| Royal Columbian Hospital | New Westminster | British Columbia | V3L 3W7 | Canada |
|
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
|
| Nova Scotia Health Authority | Halifax | Nova Scotia | B3H 3A7 | 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-Coeur 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 |
| D000070625 | Brain Injuries, Diffuse |
| D020521 | Stroke |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006331 | Heart Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D000038 | Abscess |
| D013492 | Suppuration |
| D006406 | Hematoma |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |