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Nocturnal Hypoxia in Geriatric Patients After Hip Fracture

Nocturnal Hypoxia in Patients Hospitalized in Orthogeriatrics After Hip Fracture

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04007432
Acronym
HIPOX
Enrollment
70
Registered
2019-07-05
Start date
2020-11-05
Completion date
2028-11-05
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Hypoxia

Keywords

nocturnal hypoxia, delirum developpement

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.

Interventions

OTHERpulse oxymeter

Nocturnal oxymetry data will be continuously collected during nighttime by a pulse oxymeter, covering for 1 to 3 nights.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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,...)

Design outcomes

Primary

MeasureTime frameDescription
DeliriumMonth 1Delirum or not, diagnosed with CAM (Confusion Assessment Method). Association between nocturnal hypoxia and delirium will be study.

Secondary

MeasureTime frameDescription
In-hospital complicationsMonth 1Occurrence 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 unitMonth 1Length 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 1walking status (possible with/without help, wheelchair or bedridden) Association between nocturnal hypoxia and functional status will be study.
walking speed (functional status)Month 1walking speed for 5 meter. Association between nocturnal hypoxia and functional status will be study.
Physical performance (functional status)Month 1Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons.
DependencyMonth 1Activities 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.
MortalityMonth 1Vital status will be raised
Nocturnal hypercapniaMonth 1Nocturnal hypercapnia defined by more than 10% time spent with a transcutaneous TcPCO2 ≥50mmHg

Countries

France

Contacts

CONTACTKiyoka KINUGAWA
kiyoka.kinugawa@aphp.fr01 49 59 47 53
PRINCIPAL_INVESTIGATORKiyoka KINUGAWA

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026