Nocturnal Hypoxia in Geriatric Patients After Hip Fracture

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A hivatkozás a vágólapra kerül

ÁllapotMég nem toboroz

Szponzorok

Assistance Publique - Hôpitaux de Paris

KLINIKAI VIZSGÁLAT: NCT04007432

BioSeek: nct04007432

Kulcsszavak

Absztrakt

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.

Leírás

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.

Dátumok

Utolsó ellenőrzés:	05/31/2019
Első benyújtás:	06/17/2019
Becsült beiratkozás benyújtva:	06/30/2019
Első közzététel:	07/04/2019
Utolsó frissítés beküldve:	02/16/2020
Utolsó frissítés közzétéve:	02/18/2020
A tanulmány tényleges kezdési dátuma:	02/29/2020
Becsült elsődleges befejezési dátum:	08/31/2021
A tanulmány becsült befejezési dátuma:	08/31/2021

Állapot vagy betegség

Delirium

Hypoxia

Beavatkozás / kezelés

Other: Older patients with hip fracture

Fázis

Karcsoportok

Kar	Beavatkozás / kezelés
Experimental: Older patients with hip fracture Older patients admitted for hip fracture surgery	Other: Older patients with hip fracture Nocturnal oxymetry data will be continuously collected during nighttime by a pulse oxymeter, covering for 1 to 3 nights.

Jogosultsági kritériumok

Tanulásra alkalmas korok	70 Years Nak nek 70 Years
Tanulásra alkalmas nemek	All
Egészséges önkénteseket fogad	Igen
Kritériumok	Inclusion Criteria: - age over 70 years old, - hospitalized in orthogeriatrics for hip fracture surgery - information about the study and expression of non opposition Exclusion Criteria: - patient under guardianship, - any other type of fracture associated, - oxymetry recording not possible (behavioral disorders, night stirring,...)

Eredmény

Elsődleges eredménymérők

1. Delirium [Month 1]

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

Másodlagos eredménymérők

1. 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.

2. 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.

3. 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.

4. walking status (functional status) [Month 6]

walking status (possible with/without help, wheelchair or bedridden). Association between nocturnal hypoxia and functional status will be study.

5. walking speed (functional status) [Month 1]

walking speed for 5 meter. Association between nocturnal hypoxia and functional status will be study.

6. walking speed (functional status) [Month 6]

walking speed for 5 meter. Association between nocturnal hypoxia and functional status will be study.

7. Physical performance (functional status) [Month 1]

Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons.

8. Physical performance (functional status) [Month 6]

Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons.

9. Dependency [Month 1]

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.

10. Dependency [Month 6]

11. Mortality [Month 1]

Vital status will be raised

12. Mortality [Month 6]