Nocturnal Hypoxia in Geriatric Patients After Hip Fracture

Not Applicable

Recruiting

• Conditions: Delirium; Hypoxia
• Interventions: Other: pulse oxymeter

• Registration Number: NCT04007432
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-05
• Study Start: 2020-11-05
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-24
• Primary Completion: 2025-05-05
• Study Completion: 2025-11-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• age over 70 years old,
• hospitalized in orthogeriatrics for hip fracture surgery
• information about the study and expression of non opposition
• Expected hospital stay of 5 nights or more

Exclusion Criteria

• patient under guardianship,
• any other type of fracture associated,
• oxymetry recording not possible (behavioral disorders, night stirring,...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Older patients with hip fracture	pulse oxymeter	Older patients admitted for hip fracture surgery

Primary Outcome Measures

Name	Time	Method
Delirium	Month 1	Delirum or not, diagnosed with CAM (Confusion Assessment Method). Association between nocturnal hypoxia and delirium will be study.

Secondary Outcome Measures

Name	Time	Method
In-hospital complications	Month 1	Occurrence of in-hospital complications (infection, cardiac, etc). Association between nocturnal hypoxia and others medical complications (infection, cardiac, etc) will be study.
Length of hospitalisation stay in othogeriatrics unit	Month 1	Length of stay in othogeriatrics unit. Association between nocturnal hypoxia and length of hospitalisation stay in othogeriatrics unit will be study.
walking status (functional status)	Month 1	walking status (possible with/without help, wheelchair or bedridden). Association between nocturnal hypoxia and functional status will be study.
walking speed (functional status)	Month 1	walking speed for 5 meter. Association between nocturnal hypoxia and functional status will be study.
Physical performance (functional status)	Month 1	Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons.
Dependency	Month 6	Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) are instrument to assess independent living skills.; Association between nocturnal hypoxia and independent living skills will be study.
Mortality	Month 6	Vital status will be raised
Nocturnal hypercapnia	Month 1	Nocturnal hypercapnia defined by more than 10% time spent with a transcutaneous TcPCO2 ≥50mmHg

Trial Locations

Locations (2)

Service de gériatrie, Hopital Saint Antoine; 🇫🇷 Paris, France

Service de Gériatrie Hopital de La Pitié Salpetriere; 🇫🇷 Paris, France