Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-25 @ 12:54 PM
Study NCT ID:
NCT01099995
Status:
TERMINATED
Last Update Posted:
2010-04-08
First Post:
2010-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002249', 'term': 'Carbon Monoxide Poisoning'}, {'id': 'D003128', 'term': 'Coma'}], 'ancestors': [{'id': 'D005739', 'term': 'Gas Poisoning'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006931', 'term': 'Hyperbaric Oxygenation'}], 'ancestors': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'whyStopped': 'the study was halted after the first interim analysis as there were significantly more patients who recovered at one month in the control arm', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '1989-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2000-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-07', 'studyFirstSubmitDate': '2010-04-05', 'studyFirstSubmitQcDate': '2010-04-07', 'lastUpdatePostDateStruct': {'date': '2010-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete recovery', 'timeFrame': 'at one month', 'description': 'Complete recovery was defined as an absence of symptoms reported on the self-assessment questionnaire with a normal physical exam (including normal neuropsychological functions).'}], 'secondaryOutcomes': [{'measure': 'persistent neurological sequels', 'timeFrame': 'at one month', 'description': 'Neurological sequels were considered persistent (PNS) if they were present both at hospital discharge and at one-month evaluation, regardless of the type of manifestation.'}, {'measure': 'delayed neurological sequels', 'timeFrame': 'at one month', 'description': 'Delayed neurological sequelae (DNS) were any neurological manifestations that appeared between hospital discharge and one-month evaluation, regardless of their severity. Patients with DNS were those considered fully recovered at hospital discharge but with neurological manifestations at one-month evaluation.'}, {'measure': 'the difference in carboxyhemoglobin levels before/after treatment completion', 'timeFrame': 'at 12 hours from randomization', 'description': 'the difference between serum levels of carboxyhemoglobin at baseline and those recorded immedaitely after study treatment completion'}, {'measure': 'serious adverse events', 'timeFrame': 'at one month', 'description': 'any complication of hyperbaric oxygen therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['domestic accident', 'coma', 'carbon monoxide', 'intoxication', 'acute domestic carbon monoxide poisoning'], 'conditions': ['Carbon Monoxide Poisoning']}, 'descriptionModule': {'briefSummary': 'Carbon monoxide poisoning still places a burden on the healthcare system worldwide. While oxygen therapy is the cornerstone treatment, the role and practical modalities of hyperbaric oxygen therapy (HBO) remain controversial. This study aimed at comparing two sessions of HBO at 2 absolute atmosphere and one session of HBO at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy in comatose adult victims of acute domestic carbon monoxide poisoning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients older than 15 years of age\n* admitted for domestic CO poisoning within 12 hours after the end of CO exposure\n* initial coma, regardless of consciousness at hospital admission\n* carboxyhemoglobin level at presentation greater than 10% or 5%, in smokers and non-smokers, respectively\n\nExclusion Criteria:\n\n* poisoning by more than one compound (e.g., CO plus a drug or CO plus other toxic gases such as those found in fire smoke)\n* suicide attempt\n* pregnancy\n* contraindications to HBO (circulatory collapse or pneumothorax)\n* technical obstacles to HBO\n* non domestic CO poisoning\n* difficulty in determining whether the patient experienced initial loss of consciousness or initial coma\n* consent refusal'}, 'identificationModule': {'nctId': 'NCT01099995', 'briefTitle': 'Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning', 'organization': {'class': 'OTHER', 'fullName': 'University of Versailles'}, 'officialTitle': 'Phase 3 Study of Hyperbaric Oxygen Therapy for Comatose Patients With Acute Domestic Carbon Monoxide Poisoning', 'orgStudyIdInfo': {'id': 'CO89-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'One HBO session', 'description': 'hyperbaric oxygen therapy one dive at 2 absolute atmosphere (1-hour plateau) - oxygen was delivered via a full face mask - followed by 4 hours of normobaric oxygen therapy', 'interventionNames': ['Other: Hyperbaric oxygen therapy']}, {'type': 'EXPERIMENTAL', 'label': '2 HBO sessions', 'description': 'Two sessions of hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) with oxygen delivered via a full face mask at 100% inspired oxygen fraction or via mechanical ventilation', 'interventionNames': ['Other: hyperbaric oxygen therapy']}], 'interventions': [{'name': 'Hyperbaric oxygen therapy', 'type': 'OTHER', 'description': 'one dive at 2 absolute atmosphere (1-hour plateau) with 30 min time for compression and decompression - oxygen was delivered via a full face mask at high concentration to achieve a 100% inspired fraction of oxygen or via mechanical ventilation', 'armGroupLabels': ['One HBO session']}, {'name': 'hyperbaric oxygen therapy', 'type': 'OTHER', 'description': 'two dives at 2 absolute atmosphere (1-hour plateau) with 30 min of compression and 30 min of decompression - oxygen being delivered via a full face mask at 100% inspired oxygen fraction or via mechanical ventilation', 'armGroupLabels': ['2 HBO sessions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'Raymond Poincaré Hospital', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'overallOfficials': [{'name': 'Djillali Annane, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Jean Claude Raphael', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Versailles', 'class': 'OTHER'}, 'collaborators': [{'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Christophe Misse', 'oldOrganization': 'DRRC AP-HP'}}}}