An interventional study of pulse oxymeter in Delirium and Hypoxia, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 2 sites in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic
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.
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.
933 studies on the registry are indexed under Delirium; 190 are open to participants now.
This study's planned enrollment of 70 is below the median of 112 across 550 interventional studies indexed under Delirium.
Browse Delirium studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Older patients admitted for hip fracture surgery
Other: pulse oxymeter
Nocturnal oxymetry data will be continuously collected during nighttime by a pulse oxymeter, covering for 1 to 3 nights.
Delirium
Delirum or not, diagnosed with CAM (Confusion Assessment Method). Association between nocturnal hypoxia and delirium will be study.
Time frame: Month 1
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.
Time frame: Month 1
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.
Time frame: Month 1
walking status (functional status)
walking status (possible with/without help, wheelchair or bedridden) Association between nocturnal hypoxia and functional status will be study.
Time frame: Month 1
walking status (functional status)
walking status (possible with/without help, wheelchair or bedridden). Association between nocturnal hypoxia and functional status will be study.
Time frame: Month 1
walking speed (functional status)
walking speed for 5 meter. Association between nocturnal hypoxia and functional status will be study.
Time frame: Month 1
Physical performance (functional status)
Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons.
Time frame: Month 1
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.
Time frame: Month 1
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.
Time frame: Month 6
Mortality
Vital status will be raised
Time frame: Month 1
Mortality
Vital status will be raised
Time frame: Month 6
Nocturnal hypercapnia
Nocturnal hypercapnia defined by more than 10% time spent with a transcutaneous TcPCO2 ≥50mmHg
Time frame: Month 1
Started Nov 2020 (actual). Primary completion is estimated for Nov 2028, 96 months after the start.
Of 219 non-industry interventional studies with no phase under Delirium, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 96 months is above that.
Counting every sponsor, half of 222 studies reached it within 26 months; a quarter within 12 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
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