Clinical trial NCT04007432: Nocturnal Hypoxia in Geriatric Patients After Hip Fracture
Official title: Nocturnal Hypoxia in Patients Hospitalized in Orthogeriatrics After Hip Fracture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delirium
Hypoxia
Keywords: nocturnal hypoxia
delirum developpement
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 70
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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,...)

Primary outcomes:
measure: Delirium
timeFrame: Month 1
Secondary outcomes:
measure: In-hospital complications
timeFrame: Month 1
measure: Length of hospitalisation stay in othogeriatrics unit
timeFrame: Month 1
measure: walking status (functional status)
timeFrame: Month 1
measure: walking status (functional status)
timeFrame: Month 1
measure: walking speed (functional status)
timeFrame: Month 1
measure: Physical performance (functional status)
timeFrame: Month 1
measure: Dependency
timeFrame: Month 1
measure: Dependency
timeFrame: Month 6
measure: Mortality
timeFrame: Month 1
measure: Mortality
timeFrame: Month 6
measure: Nocturnal hypercapnia
timeFrame: Month 1
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de gériatrie, Hopital Saint Antoine
city: Paris
country: France
facility: Service de Gériatrie Hopital de La Pitié Salpetriere
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Kiyoka KINUGAWA
role: PRINCIPAL_INVESTIGATOR
References: