Nocturnal Hypoxia in Geriatric Patients After Hip Fracture

NCT ID: NCT04007432

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-05

Study Completion Date

2027-02-05

Brief Summary

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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

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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

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Delirium Hypoxia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Older patients with hip fracture

Older patients admitted for hip fracture surgery

Group Type EXPERIMENTAL

pulse oxymeter

Intervention Type OTHER

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

Interventions

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pulse oxymeter

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

Intervention Type OTHER

Eligibility Criteria

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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,...)
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kiyoka KINUGAWA

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Service de gériatrie, Hopital Saint Antoine

Paris, , France

Site Status RECRUITING

Service de Gériatrie Hopital de La Pitié Salpetriere

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Kiyoka KINUGAWA

Role: CONTACT

01 49 59 47 53 ext. +33

Facility Contacts

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THOMAS Caroline

Role: primary

01 71 97 00 57

Jacques Dr BODDAERT

Role: primary

01 42 16 03 72

Other Identifiers

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2019-A01084-53

Identifier Type: OTHER

Identifier Source: secondary_id

APHP190391

Identifier Type: -

Identifier Source: org_study_id

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