Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-31 @ 9:00 AM
Study NCT ID:
NCT04007432
Status:
RECRUITING
Last Update Posted:
2025-05-25
First Post:
2019-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nocturnal Hypoxia in Geriatric Patients After Hip Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'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'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-02-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2019-06-18', 'studyFirstSubmitQcDate': '2019-07-01', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delirium', 'timeFrame': 'Month 1', 'description': 'Delirum or not, diagnosed with CAM (Confusion Assessment Method). Association between nocturnal hypoxia and delirium will be study.'}], 'secondaryOutcomes': [{'measure': 'In-hospital complications', 'timeFrame': 'Month 1', 'description': 'Occurrence of in-hospital complications (infection, cardiac, etc). Association between nocturnal hypoxia and others medical complications (infection, cardiac, etc) will be study.'}, {'measure': 'Length of hospitalisation stay in othogeriatrics unit', 'timeFrame': 'Month 1', 'description': 'Length of stay in othogeriatrics unit. Association between nocturnal hypoxia and length of hospitalisation stay in othogeriatrics unit will be study.'}, {'measure': 'walking status (functional status)', 'timeFrame': 'Month 1', 'description': 'walking status (possible with/without help, wheelchair or bedridden) Association between nocturnal hypoxia and functional status will be study.'}, {'measure': 'walking status (functional status)', 'timeFrame': 'Month 1', 'description': 'walking status (possible with/without help, wheelchair or bedridden). Association between nocturnal hypoxia and functional status will be study.'}, {'measure': 'walking speed (functional status)', 'timeFrame': 'Month 1', 'description': 'walking speed for 5 meter. Association between nocturnal hypoxia and functional status will be study.'}, {'measure': 'Physical performance (functional status)', 'timeFrame': 'Month 1', 'description': 'Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons.'}, {'measure': 'Dependency', 'timeFrame': 'Month 1', 'description': 'Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) are instrument to assess independent living skills.\n\nAssociation between nocturnal hypoxia and independent living skills will be study.'}, {'measure': 'Dependency', 'timeFrame': 'Month 6', 'description': 'Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) are instrument to assess independent living skills.\n\nAssociation between nocturnal hypoxia and independent living skills will be study.'}, {'measure': 'Mortality', 'timeFrame': 'Month 1', 'description': 'Vital status will be raised'}, {'measure': 'Mortality', 'timeFrame': 'Month 6', 'description': 'Vital status will be raised'}, {'measure': 'Nocturnal hypercapnia', 'timeFrame': 'Month 1', 'description': 'Nocturnal hypercapnia defined by more than 10% time spent with a transcutaneous TcPCO2 ≥50mmHg'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nocturnal hypoxia', 'delirum developpement'], 'conditions': ['Delirium', 'Hypoxia']}, 'descriptionModule': {'briefSummary': 'Delirium is a common complication following hip fracture surgery (HFS) in older people. Postoperative hypoxia has also been associated with delirium, but not specifically in geriatric patients. The aim of the study is to demonstrate that post-operative hypoxia is associated with in-hospital complications in patients with HFS.', 'detailedDescription': 'Patients hospitalized in orthogeriatric unit after HFS will be monitored for nocturnal SpO2 with a pulse oximeter continuously during 3 nights. In-hospital complications will be recorded prospectively in all patients, especially the occurrence of delirium with the CAM scale. The hypoxia vs non-hypoxia (more than 20% of the time spent with SpO2\\<90%) groups will be analyzed for clinical characteristics, comorbidities and medication use.\n\nThe statistical association between severe post-operative nocturnal hypoxemia and occurrence of delirium will be assessed. The dependance between this association and daytime SpO2 will also be assessed. The potential confirmation of an association between post-operative nocturnal hypoxemia in patients with HFS and the occurrence of delirium will lead the reflection on a clinical trial testing the benefit of oxygen therapy in the prevention of post-operative delirium, to improve the medical care of orthogeriatric patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 70 years old,\n* hospitalized in orthogeriatrics for hip fracture surgery\n* information about the study and expression of non opposition\n* Expected hospital stay of 5 nights or more\n\nExclusion Criteria:\n\n* patient under guardianship,\n* any other type of fracture associated,\n* oxymetry recording not possible (behavioral disorders, night stirring,...)'}, 'identificationModule': {'nctId': 'NCT04007432', 'acronym': 'HIPOX', 'briefTitle': 'Nocturnal Hypoxia in Geriatric Patients After Hip Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Nocturnal Hypoxia in Patients Hospitalized in Orthogeriatrics After Hip Fracture', 'orgStudyIdInfo': {'id': 'APHP190391'}, 'secondaryIdInfos': [{'id': '2019-A01084-53', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Older patients with hip fracture', 'description': 'Older patients admitted for hip fracture surgery', 'interventionNames': ['Other: pulse oxymeter']}], 'interventions': [{'name': 'pulse oxymeter', 'type': 'OTHER', 'description': 'Nocturnal oxymetry data will be continuously collected during nighttime by a pulse oxymeter, covering for 1 to 3 nights.', 'armGroupLabels': ['Older patients with hip fracture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'THOMAS Caroline', 'role': 'CONTACT', 'email': 'caroline.thomas@aphp.fr', 'phone': '01 71 97 00 57'}], 'facility': 'Service de gériatrie, Hopital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jacques Dr BODDAERT', 'role': 'CONTACT', 'email': 'jacques.boddaert@aphp.fr', 'phone': '01 42 16 03 72'}], 'facility': 'Service de Gériatrie Hopital de La Pitié Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Kiyoka KINUGAWA', 'role': 'CONTACT', 'email': 'kiyoka.kinugawa@aphp.fr', 'phone': '01 49 59 47 53', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Kiyoka KINUGAWA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}