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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

TypeNameDescription
OTHERpulse oxymeterNocturnal 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.

Nocturnal Hypoxia in Geriatric Patients After Hip Fracture (NCT04007432) · Clinical Trials Directory