Nocturnal Hypoxia in Geriatric Patients After Hip Fracture (HIPOX)

Nocturnal Hypoxia in Patients Hospitalized in Orthogeriatrics After Hip Fracture

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.

Study Overview

• Status: Recruiting
• Conditions: Delirium; Hypoxia
• Intervention / Treatment: Other: pulse oxymeter

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kiyoka KINUGAWA; Phone Number: +33 01 49 59 47 53; Email: kiyoka.kinugawa@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Service de Gériatrie Hopital de La Pitié Salpetriere
    • Contact: Jacques Dr BODDAERT; Phone Number: 01 42 16 03 72; Email: jacques.boddaert@aphp.fr
  • Paris, France, 75012
    • Recruiting
    • Service de gériatrie, Hopital Saint Antoine
    • Contact: THOMAS Caroline; Phone Number: 01 71 97 00 57; Email: caroline.thomas@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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,...)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Older patients with hip fracture; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium	Delirum or not, diagnosed with CAM (Confusion Assessment Method). Association between nocturnal hypoxia and delirium will be study.	Month 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
walking speed (functional status)	walking speed for 5 meter. Association between nocturnal hypoxia and functional status will be study.	Month 1
Physical performance (functional status)	Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons.	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.	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.	Month 6
Mortality	Vital status will be raised	Month 1
Mortality	Vital status will be raised	Month 6
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
Nocturnal hypercapnia	Nocturnal hypercapnia defined by more than 10% time spent with a transcutaneous TcPCO2 ≥50mmHg	Month 1

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Kiyoka KINUGAWA, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Anticipated): May 5, 2025
• Study Completion (Anticipated): November 5, 2025

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: nocturnal hypoxia; delirum developpement
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Signs and Symptoms, Respiratory; Femoral Fractures; Hip Injuries; Hip Fractures; Hypoxia
• Other Study ID Numbers: APHP190391; 2019-A01084-53 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No