DeliriumHIPOXNCT04007432
Nocturnal Hypoxia in Geriatric Patients After Hip Fracture
A study testing pulse oxymeter in people with Delirium and Hypoxia, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- What is being tested?
- pulse oxymeter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Nov 2020to 5 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- patient under guardianship,
- any other type of fracture associated,
- oxymetry recording not possible (behavioral disorders, night stirring,...)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Service de gériatrie, Hopital Saint Antoine
Paris, 75012
THOMAS Caroline, 01 71 97 00 57, caroline.thomas@aphp.fr
- Recruiting
Service de Gériatrie Hopital de La Pitié Salpetriere
Paris, 75013
Jacques Dr BODDAERT, 01 42 16 03 72, jacques.boddaert@aphp.fr
About this study
Official title: 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.
Read the 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.
- Being tested
- pulse oxymeter
- Keywords
- nocturnal hypoxia, delirum developpement
- Medical subject headings
- Delirium, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulse oxymeterOther
Nocturnal oxymetry data will be continuously collected during nighttime by a pulse oxymeter, covering for 1 to 3 nights.
| Study group | Role | What they receive |
|---|---|---|
| Older patients with hip fracture | Experimental | Older patients admitted for hip fracture surgery Receives: Other: pulse oxymeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
Delirum or not, diagnosed with CAM (Confusion Assessment Method). Association between nocturnal hypoxia and delirium will be study.
Measured: Month 1
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 1
walking speed (functional status)
walking speed for 5 meter. Association between nocturnal hypoxia and functional status will be study.
Measured: Month 1
Physical performance (functional status)
Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons.
Measured: 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.
Measured: 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.
Measured: Month 6
Mortality
Vital status will be raised
Measured: Month 1
Mortality
Vital status will be raised
Measured: Month 6
Nocturnal hypercapnia
Nocturnal hypercapnia defined by more than 10% time spent with a transcutaneous TcPCO2 ≥50mmHg
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start5 Nov 2020
- Primary completion5 Nov 2028 (estimated)
- Study completion5 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kiyoka KINUGAWA, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007432
- Sponsor's protocol ID
- APHP190391
- Other IDs
- 2019-A01084-53
- Acronym
- HIPOX
- Status last verified
- Apr 2026
- First submitted
- 18 Jun 2019
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nocturnal Hypoxia in Patients Hospitalized in Orthogeriatrics After Hip Fracture
- ClinicalTrials.gov ID
- NCT04007432
- Acronym / sponsor ID
- HIPOX / APHP190391
- Keywords
- nocturnal hypoxia, delirum developpement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 5 Nov 2028 (estimated)
- Study completion
- 5 Nov 2028 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older patients with hip fracture | Experimental | Other: pulse oxymeterOlder patients admitted for hip fracture surgery |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- patient under guardianship,
- any other type of fracture associated,
- oxymetry recording not possible (behavioral disorders, night stirring,...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulse oxymeterNocturnal oxymetry data will be continuously collected during nighttime by a pulse oxymeter, covering for 1 to 3 nights. | Other | Older patients with hip fracture |
Primary outcome
Delirium
Time frame: Month 1
Delirum or not, diagnosed with CAM (Confusion Assessment Method). Association between nocturnal hypoxia and delirium will be study.
11 secondary outcomes
In-hospital complications
Time frame: Month 1
Length of hospitalisation stay in othogeriatrics unit
Time frame: Month 1
walking status (functional status)
Time frame: Month 1
walking status (functional status)
Time frame: Month 1
walking speed (functional status)
Time frame: Month 1
Physical performance (functional status)
Time frame: Month 1
Dependency
Time frame: Month 1
Dependency
Time frame: Month 6
Mortality
Time frame: Month 1
Mortality
Time frame: Month 6
Nocturnal hypercapnia
Time frame: Month 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
Related trials for Delirium
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The Danish Out-of-Hospital Cardiac Arrest Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kiyoka KINUGAWA principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulse oxymeter in people with Delirium and Hypoxia, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kiyoka KINUGAWA (01 49 59 47 53 ext. +33, kiyoka.kinugawa@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (time frame: Month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.