Ignite Creation Date:
2025-12-24 @ 12:59 PM
Ignite Modification Date:
2026-01-01 @ 3:19 PM
Study NCT ID:
NCT00729261
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2008-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Trial of Elective Extubation in Brain Injured Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D060666', 'term': 'Airway Extubation'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-27', 'studyFirstSubmitDate': '2008-08-01', 'studyFirstSubmitQcDate': '2008-08-01', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Rankin Score', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'nosocomial pneumonias', 'timeFrame': 'hospital discharge'}, {'measure': 'reintubations', 'timeFrame': 'hospital discharge'}, {'measure': 'ICU length of stay', 'timeFrame': 'hospital discharge'}, {'measure': 'hospital length of stay', 'timeFrame': 'hospital discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mechanical ventilation', 'extubation', 'outcomes', 'brain injury'], 'conditions': ['Brain Injury']}, 'referencesModule': {'references': [{'pmid': '10806150', 'type': 'RESULT', 'citation': 'Coplin WM, Pierson DJ, Cooley KD, Newell DW, Rubenfeld GD. Implications of extubation delay in brain-injured patients meeting standard weaning criteria. Am J Respir Crit Care Med. 2000 May;161(5):1530-6. doi: 10.1164/ajrccm.161.5.9905102.'}, {'pmid': '19000302', 'type': 'DERIVED', 'citation': 'Manno EM, Rabinstein AA, Wijdicks EF, Brown AW, Freeman WD, Lee VH, Weigand SD, Keegan MT, Brown DR, Whalen FX, Roy TK, Hubmayr RD. A prospective trial of elective extubation in brain injured patients meeting extubation criteria for ventilatory support: a feasibility study. Crit Care. 2008;12(6):R138. doi: 10.1186/cc7112. Epub 2008 Nov 10.'}]}, 'descriptionModule': {'briefSummary': 'Identifying the optimal time of extubation in a brain injured population should improve patient outcome. Brain injured patients usually remain intubated due to concerns of airway maintenance. Current practice argues that unconscious patients need to remain intubated to protect their airways. More recent data however suggests that delaying extubation in this population increases pneumonias and worsens patient outcomes.\n\nWe designed a safety and feasibility study of randomizing brain injured patients into early or delayed extubation. The purpose was to gain insight into patient safety concerns and to obtain estimates of sample size needed for a larger study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Resolution or improvement of any pulmonary process requiring mechanical ventilation.\n2. Adequate gas exchange.\n3. Adequate ventilation.\n4. Respiratory rate to tidal volume ratio \\<105.\n5. Core body temperature \\< 38 degrees celsius.\n6. Hemoglobin \\> 8 grams per deciliter.\n7. No sedative medications for 2 hours.\n\nNeurological requirements included:\n\n1. GCS ≤ 8.\n2. Intracranial pressure (ICP) \\< 15 cm of water and a cerebral perfusion pressure (CPP) \\> 60 mm Hg for patients with intracranial pressure monitors.\n\nExclusion Criteria:\n\n1. Age \\< 18 years.\n2. Lack of informed consent by the patients' surrogate.\n3. Dependence on mechanical ventilation for at least two weeks prior to enrollment.\n4. Patients with tracheostomies.\n5. Intubation instituted for therapeutic hyperventilation.\n6. Planned surgical or radiological intervention within the next 72 hours.\n7. Anticipated neurological or medically worsening conditions (i.e develop cerebral edema or vasospasm).\n8. Patients intubated for airway preservation due to airway edema (cervical neck injuries or surgery) as opposed to airway protection."}, 'identificationModule': {'nctId': 'NCT00729261', 'briefTitle': 'A Prospective Trial of Elective Extubation in Brain Injured Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Prospective Trial of Elective Extubation in Brain Injured Patients Meeting Extubation Criteria for Ventilatory Support.', 'orgStudyIdInfo': {'id': '1210-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'armA I', 'description': 'Patients remain intubated until the patients Glasgow coma score improves to greater than 8.', 'interventionNames': ['Procedure: continued intubation']}, {'type': 'EXPERIMENTAL', 'label': 'arm 2', 'description': 'Patients that meet standard airway and ventilatory criteria for extubation but have a Glasgow coma score of less than or equal to 8 are immediately extubated.', 'interventionNames': ['Procedure: extubation']}], 'interventions': [{'name': 'extubation', 'type': 'PROCEDURE', 'description': 'Brian injured patients that remained intubation solely because of a depressed level of consciousness were randomized into immediate extubation or delayed extubation until their level of consciousness improved.All patients met standard ventilatory, and airway criteria for extubation.', 'armGroupLabels': ['arm 2']}, {'name': 'continued intubation', 'type': 'PROCEDURE', 'description': 'patients remain intubated until their Glasgow coma scores improve to greater than 8.', 'armGroupLabels': ['armA I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Edward M. Manno, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Edward M. Manno M.D.', 'oldOrganization': 'Mayo Clinic'}}}}