Nocturnal Hypoxia in Geriatric Patients After Hip Fracture

Delirium Clinical Trial

— HIPOX  

Official title:

Nocturnal Hypoxia in Patients Hospitalized in Orthogeriatrics After Hip Fracture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04007432
• Other study ID #: APHP190391
• Secondary ID: 2019-A01084-53
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2020
• Est. completion date: November 5, 2025

Study information

• Verified date: April 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Kiyoka KINUGAWA
• Phone: 01 49 59 47 53
• Email: kiyoka.kinugawa[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 5, 2025
• Est. primary completion date: May 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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,...)

Related Conditions & MeSH terms

• Delirium
• Hip Fractures
• Hypoxia

Intervention

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

Locations

Country	Name	City	State
France	Service de Gériatrie Hopital de La Pitié Salpetriere	Paris
France	Service de gériatrie, Hopital Saint Antoine	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium	Delirum or not, diagnosed with CAM (Confusion Assessment Method). Association between nocturnal hypoxia and delirium will be study.	Month 1
Secondary	In-hospital complications	Occurrence of in-hospital complications (infection, cardiac, etc). Association between nocturnal hypoxia and others medical complications (infection, cardiac, etc) will be study.	Month 1
Secondary	Length of hospitalisation stay in othogeriatrics unit	Length of stay in othogeriatrics unit. Association between nocturnal hypoxia and length of hospitalisation stay in othogeriatrics unit will be study.	Month 1
Secondary	walking status (functional status)	walking status (possible with/without help, wheelchair or bedridden) Association between nocturnal hypoxia and functional status will be study.	Month 1
Secondary	walking status (functional status)	walking status (possible with/without help, wheelchair or bedridden). Association between nocturnal hypoxia and functional status will be study.	Month 1
Secondary	walking speed (functional status)	walking speed for 5 meter. Association between nocturnal hypoxia and functional status will be study.	Month 1
Secondary	Physical performance (functional status)	Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons.	Month 1
Secondary	Dependency	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.	Month 1
Secondary	Dependency	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.	Month 6
Secondary	Mortality	Vital status will be raised	Month 1
Secondary	Mortality	Vital status will be raised	Month 6
Secondary	Nocturnal hypercapnia	Nocturnal hypercapnia defined by more than 10% time spent with a transcutaneous TcPCO2 =50mmHg	Month 1