Trials / Recruiting
RecruitingNCT04007432
Nocturnal Hypoxia in Geriatric Patients After Hip Fracture
Nocturnal Hypoxia in Patients Hospitalized in Orthogeriatrics After Hip Fracture
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Academic / Other
- Sex
- All
- Age
- 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | pulse oxymeter | Nocturnal oxymetry data will be continuously collected during nighttime by a pulse oxymeter, covering for 1 to 3 nights. |
Timeline
- Start date
- 2020-11-05
- Primary completion
- 2027-02-05
- Completion
- 2027-02-05
- First posted
- 2019-07-05
- Last updated
- 2025-05-25
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT04007432. Inclusion in this directory is not an endorsement.