Nocturnal Hypoxia in Geriatric Patients After Hip Fracture
HIPOX
Nocturnal Hypoxia in Patients Hospitalized in Orthogeriatrics After Hip Fracture
2 other identifiers
interventional
70
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2020
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedStudy Start
First participant enrolled
November 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 5, 2028
May 4, 2026
April 1, 2026
8 years
June 18, 2019
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Delirium
Delirum or not, diagnosed with CAM (Confusion Assessment Method). Association between nocturnal hypoxia and delirium will be study.
Month 1
Secondary Outcomes (11)
In-hospital complications
Month 1
Length of hospitalisation stay in othogeriatrics unit
Month 1
walking status (functional status)
Month 1
walking status (functional status)
Month 1
walking speed (functional status)
Month 1
- +6 more secondary outcomes
Study Arms (1)
Older patients with hip fracture
EXPERIMENTALOlder patients admitted for hip fracture surgery
Interventions
Nocturnal oxymetry data will be continuously collected during nighttime by a pulse oxymeter, covering for 1 to 3 nights.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- patient under guardianship,
- any other type of fracture associated,
- oxymetry recording not possible (behavioral disorders, night stirring,...)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Service de gériatrie, Hopital Saint Antoine
Paris, 75012, France
Service de Gériatrie Hopital de La Pitié Salpetriere
Paris, 75013, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kiyoka KINUGAWA
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2019
First Posted
July 5, 2019
Study Start
November 5, 2020
Primary Completion (Estimated)
November 5, 2028
Study Completion (Estimated)
November 5, 2028
Last Updated
May 4, 2026
Record last verified: 2026-04