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:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Nocturnal Hypoxia in Patients Hospitalized in Orthogeriatrics After Hip Fracture
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIPOX
Brief Summary:
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.
Detailed Description:
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.
The 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.
The 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-A01084-53 | OTHER | ANSM | View |