Nocturnal Hypoxia in Geriatric Patients After Hip Fracture
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: pulse oxymeter.
- Who it may be relevant to
- Registry conditions: Delirium, Hypoxia. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Nocturnal Hypoxia in Patients Hospitalized in Orthogeriatrics After Hip Fracture
Overview
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.
Interventions
- Other pulse oxymeter
Nocturnal oxymetry data will be continuously collected during nighttime by a pulse oxymeter, covering for 1 to 3 nights.
Primary outcome measures
- Delirium [Time frame: Month 1]
Secondary outcome measures (11)
- In-hospital complications [Time frame: Month 1]
- Length of hospitalisation stay in othogeriatrics unit [Time frame: Month 1]
- walking status (functional status) [Time frame: Month 1]
- walking status (functional status) [Time frame: Month 1]
- walking speed (functional status) [Time frame: Month 1]
- Physical performance (functional status) [Time frame: Month 1]
- Dependency [Time frame: Month 1]
- Dependency [Time frame: Month 6]
- Mortality [Time frame: Month 1]
- Mortality [Time frame: Month 6]
- Nocturnal hypercapnia [Time frame: Month 1]
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,...)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 2 centers
- Service de gériatrie, Hopital Saint Antoine — Paris
- Service de Gériatrie Hopital de La Pitié Salpetriere — Paris
Identifiers
NCT: NCT04007432 · APHP190391 · 2019-A01084-53