search
Back to results

Nocturnal Hypoxia in Geriatric Patients After Hip Fracture (HIPOX)

Primary Purpose

Delirium, Hypoxia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
pulse oxymeter
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Delirium focused on measuring nocturnal hypoxia, delirum developpement

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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,...)

Sites / Locations

  • Service de gériatrie, Hopital Saint AntoineRecruiting
  • Service de Gériatrie Hopital de La Pitié SalpetriereRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Older patients with hip fracture

Arm Description

Older patients admitted for hip fracture surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
walking status (functional status)
walking status (possible with/without help, wheelchair or bedridden) Association between nocturnal hypoxia and functional status will be study.
walking status (functional status)
walking status (possible with/without help, wheelchair or bedridden). Association between nocturnal hypoxia and functional status will be study.
walking speed (functional status)
walking speed for 5 meter. Association between nocturnal hypoxia and functional status will be study.
Physical performance (functional status)
Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons.
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.
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.
Mortality
Vital status will be raised
Mortality
Vital status will be raised
Nocturnal hypercapnia
Nocturnal hypercapnia defined by more than 10% time spent with a transcutaneous TcPCO2 ≥50mmHg

Full Information

First Posted
June 18, 2019
Last Updated
April 21, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT04007432
Brief Title
Nocturnal Hypoxia in Geriatric Patients After Hip Fracture
Acronym
HIPOX
Official Title
Nocturnal Hypoxia in Patients Hospitalized in Orthogeriatrics After Hip Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
May 5, 2025 (Anticipated)
Study Completion Date
November 5, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Hypoxia
Keywords
nocturnal hypoxia, delirum developpement

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Older patients with hip fracture
Arm Type
Experimental
Arm Description
Older patients admitted for hip fracture surgery
Intervention Type
Other
Intervention Name(s)
pulse oxymeter
Intervention Description
Nocturnal oxymetry data will be continuously collected during nighttime by a pulse oxymeter, covering for 1 to 3 nights.
Primary Outcome Measure Information:
Title
Delirium
Description
Delirum or not, diagnosed with CAM (Confusion Assessment Method). Association between nocturnal hypoxia and delirium will be study.
Time Frame
Month 1
Secondary Outcome Measure Information:
Title
In-hospital complications
Description
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
Title
Length of hospitalisation stay in othogeriatrics unit
Description
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
Title
walking status (functional status)
Description
walking status (possible with/without help, wheelchair or bedridden) Association between nocturnal hypoxia and functional status will be study.
Time Frame
Month 1
Title
walking status (functional status)
Description
walking status (possible with/without help, wheelchair or bedridden). Association between nocturnal hypoxia and functional status will be study.
Time Frame
Month 1
Title
walking speed (functional status)
Description
walking speed for 5 meter. Association between nocturnal hypoxia and functional status will be study.
Time Frame
Month 1
Title
Physical performance (functional status)
Description
Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons.
Time Frame
Month 1
Title
Dependency
Description
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
Title
Dependency
Description
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
Title
Mortality
Description
Vital status will be raised
Time Frame
Month 1
Title
Mortality
Description
Vital status will be raised
Time Frame
Month 6
Title
Nocturnal hypercapnia
Description
Nocturnal hypercapnia defined by more than 10% time spent with a transcutaneous TcPCO2 ≥50mmHg
Time Frame
Month 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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,...)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kiyoka KINUGAWA
Phone
01 49 59 47 53
Ext
+33
Email
kiyoka.kinugawa@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiyoka KINUGAWA
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de gériatrie, Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
THOMAS Caroline
Phone
01 71 97 00 57
Email
caroline.thomas@aphp.fr
Facility Name
Service de Gériatrie Hopital de La Pitié Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Dr BODDAERT
Phone
01 42 16 03 72
Email
jacques.boddaert@aphp.fr

12. IPD Sharing Statement

Learn more about this trial

Nocturnal Hypoxia in Geriatric Patients After Hip Fracture

We'll reach out to this number within 24 hrs