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NCT Number: NCT04007432

Nocturnal Hypoxia in Geriatric Patients 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.

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Key information

Conditions

Delirium Confusion Hypoxia Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Gériatrie Hopital de La Pitié Salpetriere, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,...)

Treatment and study plan

pulse oxymeter

Other

Nocturnal oxymetry data will be continuously collected during nighttime by a pulse oxymeter, covering for 1 to 3 nights.

Primary outcomes

  1. Delirium

    Time frame: Month 1

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

Secondary outcomes

  1. In-hospital complications

    Time frame: Month 1

    Occurrence of in-hospital complications (infection, cardiac, etc). Association between nocturnal hypoxia and others medical complications (infection, cardiac, etc) will be study.

  2. Length of hospitalisation stay in othogeriatrics unit

    Time frame: Month 1

    Length of stay in othogeriatrics unit. Association between nocturnal hypoxia and length of hospitalisation stay in othogeriatrics unit will be study.

  3. walking status (functional status)

    Time frame: Month 1

    walking status (possible with/without help, wheelchair or bedridden) Association between nocturnal hypoxia and functional status will be study.

  4. walking status (functional status)

    Time frame: Month 1

    walking status (possible with/without help, wheelchair or bedridden). Association between nocturnal hypoxia and functional status will be study.

  5. walking speed (functional status)

    Time frame: Month 1

    walking speed for 5 meter. Association between nocturnal hypoxia and functional status will be study.

  6. Physical performance (functional status)

    Time frame: Month 1

    Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons.

  7. Dependency

    Time frame: Month 1

    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.

  8. Dependency

    Time frame: Month 6

    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.

  9. Mortality

    Time frame: Month 1

    Vital status will be raised

  10. Mortality

    Time frame: Month 6

    Vital status will be raised

  11. Nocturnal hypercapnia

    Time frame: Month 1

    Nocturnal hypercapnia defined by more than 10% time spent with a transcutaneous TcPCO2 ≥50mmHg

Study contacts

Contact information is provided by the study sponsor or research team.

Kiyoka KINUGAWA

CONTACT

[email protected]

01 49 59 47 53 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Nocturnal Hypoxia in Patients Hospitalized in Orthogeriatrics After Hip Fracture

Acronym: HIPOX

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Jul 5, 2019
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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