Hip Fractures (ICD-10 72.01-72.2)NCT07189260
Pre- and Postoperative Chest Therapy With Positive Expiratory Pressure (PEP) to Prevent Hospital-acquired Pneumonia
A study testing positive expiratory pressure in people with Hip Fractures (ICD-10 72.01-72.2), run by University Hospital Bispebjerg and Frederiksberg at 2 sites in Denmark.
Trial summary
The goal of this clinical trial is to investigate whether pre- and postoperative treatment with systematic PEP therapy can prevent hospital-acquired pneumonia in patients with hip frac-ture. It will also learn about the barriers regarding PEP therapy in this group of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures (ICD-10 72.01-72.2)
- What is being tested?
- positive expiratory pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- 2 sitesDenmark
- Study dates
- 19 Feb 2024to 31 Dec 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hip fracture regardless of age
- Cognitively well-functioning
- Able to understand the study and give informed consent
- Able to speak and understand Danish
- Resident of Region Hovedstaden or Region Sjælland
Who cannot join
- Cognitively impaired
- Unable to understand the study and give informed consent
- Pneumonia upon admission
- Delirium upon admission
- Pneumothorax
- For patients with e.g. dementia or brain injury, the ability to give informed consent will be assessed individually.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Bispebjerg & Frederiksberg Hospital
Copenhagen, 2400
Ditte Stensgaard Andreasen, +4521283123, ditte.stensgaard.andreasen@regionh.dk
Charlotte Densing Petersen, charlotte.densing.petersen.01@regionh.dk
- Recruiting
Herlev & Gentofte Hospital
Herlev, 2730
Camilla Paaske, +4538689682, camilla.paaske@regionh.dk
Camilla Paaske
About this study
Official title: Pre- and Postoperative Chest Therapy With Positive Expiratory Pressure (PEP) to Prevent Hospital-acquired Pneumonia in Patients Undergoing Hip Fracture Surgery
The goal of this clinical trial is to investigate whether pre- and postoperative treatment with systematic PEP therapy can prevent hospital-acquired pneumonia in patients with hip frac-ture. It will also learn about the barriers regarding PEP therapy in this group of patients.
- Does pre- and postoperative treatment with systematic PEP therapy prevent hospital-acquired pneumonia in patients with hip fracture?
- Which barriers do participants have regarding PEP therapy in this group of patients? Researchers will compare systematic PEP therapy to no intervention besides standard treat-ment to see if systematic therapy with PEP can prevent hospital-acquired pneumonia.
Read more
Participants will:
- Receive systematic PEP therapy during hospitalization or no intervention besides standard treatment
- Register the PEP therapy four times daily on a paper checklist. Failure to perform the treatment and the reason must also be documented on the checklist.
- Conditions
- Hip Fractures (ICD-10 72.01-72.2)
- Being tested
- positive expiratory pressure
- Keywords
- hip fracture, pneumonia, PEP therapy, positive expiratory pressure, RCT, hospital-acquired pneumonia, systematic treatment with PEP, osteoporosis, frailty, multimorbidity
- Medical subject headings
- Hip Fractures, Pneumonia, Healthcare-Associated Pneumonia, Osteoporosis, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positive expiratory pressureDevice
PEP therapy
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Medical therapy device Receives: Device: positive expiratory pressure |
| Standard treatment | No intervention | Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hospital-acquired pneumonia
Primary Outcome is the incidence of hospital-acquired pneumonia in the control and intervention group. Documented in the Sundhedsplatformen and diagnosed with one ore more of the following:
- Thoracic x-ray
- Sputum culture
- Auscultation
- Infection markers
Measured: During hospitalization, from intervention start to discharge, which is on average one week
Secondary outcomes (5)
Number of participants dead within 30-days after discharge
Number of participants dead within 30 days after discharge
Measured: 30-day mortality, assessed 30 days after discharge from the orthopedic ward
Number of participants readmitted within 30-days after discharge
Number of participants readmitted within 30 days after discharge
Measured: 30-day readmission post-discharge, assessed 30 days after discharge from the orthopedic ward
Incidence of delirium during hospitalization (journal entry, CAM-screening, diagnosis), up to 4 weeks.
Incidence of delirium during hospitalization (journal entry, CAM-screening, diagnosis), up to 4 weeks.
Measured: During hospitalization, from intervention start to discharge, which is on average one week
Degree of regained basic mobility (Cumulated Ambulation Score - CAS) on the the day of discharge compared to the assement made at admission.
Degree of regained basic mobility (Cumulated Ambulation Score - CAS) on the the day of discharge compared to the assement made at admission. CAS values ranges from 0 to 6. A score of 6 represents an independant patient in regards to getting in and out of bed, sit-to-stand from a chair, and walking. A score of 0 represents a patient completely dependant on help getting in and out of bed, sit-to-stand from a chair, and walking.
Measured: CAS the weeks up to hip fracture and CAS at discharge, which is on average one week after admission
Discharge destination (home, nursing home, care facility, rehab, another ward/hospital, etc.). Number of participants discharged to home, care facility, rehab, another hospital/ward or ot he discharge destination.
Discharge destination (home, nursing home, care facility, rehab, another ward/hospital, etc.). Number of participants discharged to home, care facility, rehab, another hospital/ward or o the discharge destination.
Measured: Assessed at discharge from the orthopedic department, which is on average one week efter admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start19 Feb 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Fractures (ICD-10 72.01-72.2)Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 566 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte Densing, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189260
- Sponsor's protocol ID
- PEP trial
- Status last verified
- Aug 2025
- First submitted
- 11 Jun 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), will be provided to anyone who wishes to access the data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre- and Postoperative Chest Therapy With Positive Expiratory Pressure (PEP) to Prevent Hospital-acquired Pneumonia in Patients Undergoing Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT07189260
- Acronym / sponsor ID
- PEP trial
- Conditions
- Hip Fractures (ICD-10 72.01-72.2)
- Keywords
- hip fracture, pneumonia, PEP therapy, positive expiratory pressure, RCT, hospital-acquired pneumonia, systematic treatment with PEP, osteoporosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 566 participants (estimated)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 23 Sep 2025 (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.
The goal of this clinical trial is to investigate whether pre- and postoperative treatment with systematic PEP therapy can prevent hospital-acquired pneumonia in patients with hip frac-ture. It will also learn about the barriers regarding PEP therapy in this group of patients.
- Does pre- and postoperative treatment with systematic PEP therapy prevent hospital-acquired pneumonia in patients with hip fracture?
- Which barriers do participants have regarding PEP therapy in this group of patients? Researchers will compare systematic PEP therapy to no intervention besides standard treat-ment to see if systematic therapy with PEP can prevent hospital-acquired pneumonia.
Participants will:
- Receive systematic PEP therapy during hospitalization or no intervention besides standard treatment
- Register the PEP therapy four times daily on a paper checklist. Failure to perform the treatment and the reason must also be documented on the checklist.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: positive expiratory pressureMedical therapy device |
| Standard treatment | No intervention | –Standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hip fracture regardless of age
- Cognitively well-functioning
- Able to understand the study and give informed consent
- Able to speak and understand Danish
- Resident of Region Hovedstaden or Region Sjælland
Key exclusion criteria (6 listed)
- Cognitively impaired
- Unable to understand the study and give informed consent
- Pneumonia upon admission
- Delirium upon admission
- Pneumothorax
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 |
|---|---|---|
| positive expiratory pressurePEP therapy | Device | Active |
Primary outcome
The incidence of hospital-acquired pneumonia
Time frame: During hospitalization, from intervention start to discharge, which is on average one week
Primary Outcome is the incidence of hospital-acquired pneumonia in the control and intervention group. Documented in the Sundhedsplatformen and diagnosed with one ore more of the following: * Thoracic x-ray * Sputum culture * Auscultation * Infection markers
5 secondary outcomes
Number of participants dead within 30-days after discharge
Time frame: 30-day mortality, assessed 30 days after discharge from the orthopedic ward
Number of participants readmitted within 30-days after discharge
Time frame: 30-day readmission post-discharge, assessed 30 days after discharge from the orthopedic ward
Incidence of delirium during hospitalization (journal entry, CAM-screening, diagnosis), up to 4 weeks.
Time frame: During hospitalization, from intervention start to discharge, which is on average one week
Degree of regained basic mobility (Cumulated Ambulation Score - CAS) on the the day of discharge compared to the assement made at admission.
Time frame: CAS the weeks up to hip fracture and CAS at discharge, which is on average one week after admission
Discharge destination (home, nursing home, care facility, rehab, another ward/hospital, etc.). Number of participants discharged to home, care facility, rehab, another hospital/ward or ot he discharge destination.
Time frame: Assessed at discharge from the orthopedic department, which is on average one week efter admission
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 23 Sep 2025.
- Individual participant dataSharing planned: Yes. Access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), will be provided to anyone who wishes to access the data.
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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.
Bispebjerg & Frederiksberg Hospital
Copenhagen, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positive expiratory pressure in people with Hip Fractures (ICD-10 72.01-72.2), run by University Hospital Bispebjerg and Frederiksberg at 2 sites in Denmark.
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 5 inclusion and 6 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 23 Sep 2025. 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 Denmark. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of hospital-acquired pneumonia (time frame: During hospitalization, from intervention start to discharge, which is on average one week). 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 23 Sep 2025.