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Clinical Trials/NCT04007432
NCT04007432
Recruiting
Not Applicable

Nocturnal Hypoxia in Patients Hospitalized in Orthogeriatrics After Hip Fracture

Assistance Publique - Hôpitaux de Paris2 sites in 1 country70 target enrollmentNovember 5, 2020
ConditionsDeliriumHypoxia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
70
Locations
2
Primary Endpoint
Delirium
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 5, 2020
End Date
February 5, 2027
Last Updated
11 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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,...)

Outcomes

Primary Outcomes

Delirium

Time Frame: Month 1

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

Secondary Outcomes

  • In-hospital complications(Month 1)
  • Length of hospitalisation stay in othogeriatrics unit(Month 1)
  • walking status (functional status)(Month 1)
  • walking speed (functional status)(Month 1)
  • Physical performance (functional status)(Month 1)
  • Dependency(Month 6)
  • Mortality(Month 6)
  • Nocturnal hypercapnia(Month 1)

Study Sites (2)

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