Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
Study NCT ID:
NCT04291235
Status:
UNKNOWN
Last Update Posted:
2020-03-02
First Post:
2020-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The NEUROlogically-impaired Extubation Timing Trial (NEURO-ETT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D020833', 'term': 'Diffuse Axonal Injury'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D001922', 'term': 'Brain Abscess'}, {'id': 'D046748', 'term': 'Hematoma, Epidural, Spinal'}, {'id': 'D006408', 'term': 'Hematoma, Subdural'}, {'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000070625', 'term': 'Brain Injuries, Diffuse'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000038', 'term': 'Abscess'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D006406', 'term': 'Hematoma'}, {'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 332}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-27', 'studyFirstSubmitDate': '2020-02-03', 'studyFirstSubmitQcDate': '2020-02-27', 'lastUpdatePostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Duration of Mechanical Ventilation', 'timeFrame': 'Up to 60 Days', 'description': 'Total duration of mechanical ventilation (to 60 days) accounting for the competing risk of death'}], 'secondaryOutcomes': [{'measure': 'Mortality at ICU discharge and Hospital Discharge', 'timeFrame': 'ICU Discharge, Hospital Discharge, 3 months, and 6 months', 'description': 'Mortality at ICU Discharge, Hospital Discharge, 3 months, and 6 months'}, {'measure': 'Ventilator-Free Days at Day 60', 'timeFrame': 'Up to 60 days', 'description': 'Days alive and not receiving mechanical ventilation'}, {'measure': 'ICU Free Days At Day 60', 'timeFrame': 'Up to 60 Days', 'description': 'ICU free days (days alive and not spent in an ICU)'}, {'measure': 'Airway or Tracheostomy complications', 'timeFrame': 'Up to 30 days', 'description': 'Presence versus absence of airway complication'}, {'measure': 'Nutrition Intake', 'timeFrame': 'Up to 6 Months', 'description': 'Time to normal oral nutrition intake'}, {'measure': 'Antibiotics Days', 'timeFrame': 'Up to 30 Days', 'description': 'Injection or infusion of antibiotics given intravenously'}, {'measure': 'Tracheostomy Rates', 'timeFrame': 'Up to 6 Months', 'description': 'Presence versus absence of tracheostomy insertion'}, {'measure': 'ICU Readmission Rates', 'timeFrame': 'Hospital discharge, up to 90 days', 'description': 'ICU readmission rates to hospital discharge'}, {'measure': 'Discharge Destination', 'timeFrame': 'Hospital discharge, up to 90 days', 'description': 'Discharge destination for the patient post hospitalization'}, {'measure': 'Extended Glasgow Outcome Score', 'timeFrame': '3 months and 6 months', 'description': 'Minimum score 1 (worst) to maximum score 8 (best) at 3 months and 6 months'}, {'measure': 'EuroQol-5D', 'timeFrame': '3 months and 6 months', 'description': 'Minimum score 1 (worst) to maximum score 100 (best) at 3 months and 6 months'}, {'measure': 'Delirium Free Days', 'timeFrame': 'Up to 30 Days', 'description': 'Days alive and free of delirium while in ICU up to day 30'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Subarachnoid Hemorrhage', 'Diffuse Axonal Injury', 'Ischemic Stroke', 'Intracerebral Hemorrhage', 'Brain Tumor', 'Global Cerebral Anoxia/Cardiac Arrest', 'Meningitis/Encephalitis', 'Cerebral Abscess', 'Epidural Hematoma', 'Subdural Hematoma', 'Seizure'], 'conditions': ['Acute Brain Injury']}, 'referencesModule': {'references': [{'pmid': '39585965', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 16 years\n2. Acute brain injury (subarachnoid hemorrhage, diffuse axonal injury, ischemic stroke, intracerebral hemorrhage, brain tumor, global cerebral anoxia/cardiac arrest, meningitis/encephalitis, cerebral abscess, epidural hematoma, subdural hematoma, seizure) that occurred within the previous 4 weeks\n3. Receiving mechanical ventilation via endotracheal tube for ≥ 48 hours\n\nExclusion Criteria:\n\n1. Quadriplegic\n2. 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\n3. Do-Not-Reintubate order in place\n4. Previously randomized in this trial\n5. Underlying pre-existing condition with life expectancy less than 6-months\n6. Current enrolment in an RCT that precludes NEURO-ETT co-enrollment'}, 'identificationModule': {'nctId': 'NCT04291235', 'briefTitle': 'The NEUROlogically-impaired Extubation Timing Trial (NEURO-ETT)', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'The NEUROlogically-impaired Extubation Timing Trial', 'orgStudyIdInfo': {'id': 'NEURO-ETT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Airway Management Pathway', 'description': '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', 'interventionNames': ['Procedure: Airway Management Pathway']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': "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", 'interventionNames': ['Procedure: Usual Care']}], 'interventions': [{'name': 'Airway Management Pathway', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Airway Management Pathway']}, {'name': 'Usual Care', 'type': 'PROCEDURE', 'description': "Patients in this group will be treated according to usual care, which may include extubation or tracheostomy timed according to treating physicians' discretion.", 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'contacts': [{'name': 'David Zygun, MD', 'role': 'CONTACT', 'email': 'zygun@ualberta.ca', 'phone': '780-492-8597'}], 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V3L 3W7', 'city': 'New Westminster', 'state': 'British Columbia', 'country': 'Canada', 'contacts': [{'name': 'Steven Reynolds, MD', 'role': 'CONTACT', 'email': 'steven.reynolds@fraserhealth.ca'}], 'facility': 'Royal Columbian Hospital', 'geoPoint': {'lat': 49.20678, 'lon': -122.91092}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'contacts': [{'name': 'Donald Griesdale, MD', 'role': 'CONTACT', 'email': 'Donald.Griesdale@vch.ca', 'phone': '604-875-4304'}], 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3H 3A7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'contacts': [{'name': 'Laurel Murphey, MD', 'role': 'CONTACT', 'email': 'laurel.murphy@nshealth.ca', 'phone': '902-473-3486'}], 'facility': 'Nova Scotia Health Authority', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Sunjay Sharma, MD', 'role': 'CONTACT', 'email': 'sharmasun@hhsc.ca', 'phone': '905-521-2100', 'phoneExt': '44721'}], 'facility': 'Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'J. Gordon Boyd, MD', 'role': 'CONTACT', 'email': '2jgb1@queensu.ca', 'phone': '613-549-6666', 'phoneExt': '6228'}], 'facility': 'Kingston General Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Karen Bosma, MD', 'role': 'CONTACT', 'email': 'Karenj.Bosma@lhsc.on.ca', 'phone': '519-663-3531'}], 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Shane English, MD', 'role': 'CONTACT', 'email': 'senglish@ohri.ca', 'phone': '613-737-8726'}], 'facility': 'Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Damon Scales, MD', 'role': 'CONTACT', 'email': 'damon.scales@sunnybrook.ca', 'phone': '416-480-6100', 'phoneExt': '5291'}], 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Andrew Baker, MD', 'role': 'CONTACT', 'email': 'bakera@smh.ca', 'phone': '416-864-5559'}], 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Jeff Singh, MD', 'role': 'CONTACT', 'email': 'Jeff.Singh@uhn.ca', 'phone': '416-603-5800', 'phoneExt': '3221'}], 'facility': 'Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2X 2H8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'contacts': [{'name': 'Michaël Chassé, MD', 'role': 'CONTACT', 'email': 'michael.chasse.chum@ssss.gouv.qc.ca', 'phone': '514-890-8000', 'phoneExt': '30816'}], 'facility': "Centre hospitalier de l'Université de Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'contacts': [{'name': 'Emmanuel Charbonney, MD', 'role': 'CONTACT', 'email': 'emmanuel.charbonney@umontreal.ca', 'phone': '514 338 2050'}], 'facility': 'Hôpital du Sacré-Coeur de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1J 1Z4', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'contacts': [{'name': 'Alexis Turgeon, MD', 'role': 'CONTACT', 'email': 'alexis.turgeon@fmed.ulaval.ca', 'phone': '418-649-0252', 'phoneExt': '66064'}], 'facility': "L'Hôpital de l'Enfant-Jésus", 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Venika Manoharan, HBSc', 'role': 'CONTACT', 'email': 'venika.manoharan@sunnybrook.ca', 'phone': '416-480-6100', 'phoneExt': '88136'}], 'overallOfficials': [{'name': 'Niall Ferguson, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto General Hospital'}, {'name': 'Damon Scales, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Critical Care Medicine', 'investigatorFullName': 'Dr. Damon Scales', 'investigatorAffiliation': 'Sunnybrook Health Sciences Centre'}}}}