Pre- and Postoperative Chest Therapy With Positive Expiratory Pressure (PEP) to Prevent Hospital-acquired Pneumonia

NCT07189260 — Not applicable, Recruiting, 566 participants, University Hospital Bispebjerg and Frederiksberg

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Pre- and Postoperative Chest Therapy With Positive Expiratory Pressure (PEP) to Prevent Hospital-acquired Pneumonia in Patients Undergoing Hip Fracture Surgery

Registry	NCT07189260
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	566 (Estimated)
Sponsor	University Hospital Bispebjerg and Frederiksberg (Other)
Conditions	Hip Fractures (ICD-10 72.01-72.2)
Interventions	positive expiratory pressure (Device)
Dates	start 2024-02-19, primary completion 2029-12-31 (estimated), completion 2030-12-31 (estimated), first posted 2025-09-23, last updated 2025-09-23
Locations	2 sites in Denmark

-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.

* 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.

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+Arms and interventions

Arm	Type	Interventions	Description
Active	Active comparator	Device: positive expiratory pressure	Medical therapy device
Standard treatment	No intervention		Standard treatment

positive expiratory pressure (Device): PEP therapy

+Outcome measures

Primary outcomes

The incidence of hospital-acquired pneumonia [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

Secondary outcomes

Number of participants dead within 30-days after discharge [30-day mortality, assessed 30 days after discharge from the orthopedic ward]: Number of participants dead within 30 days after discharge
Number of participants readmitted within 30-days after discharge [30-day readmission post-discharge, assessed 30 days after discharge from the orthopedic ward]: Number of participants readmitted within 30 days after discharge
Incidence of delirium during hospitalization (journal entry, CAM-screening, diagnosis), up to 4 weeks. [During hospitalization, from intervention start to discharge, which is on average one week]: Incidence of delirium during hospitalization (journal entry, CAM-screening, diagnosis), up to 4 weeks.
Degree of regained basic mobility (Cumulated Ambulation Score - CAS) on the the day of discharge compared to the assement made at admission. [CAS the weeks up to hip fracture and CAS at discharge, which is on average one week after 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.
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. [Assessed at discharge from the orthopedic department, which is on average one week efter 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 o the discharge destination.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

+Locations (2)

Facility	City	Country	Status
Bispebjerg & Frederiksberg Hospital	Copenhagen	Denmark	Recruiting
Herlev & Gentofte Hospital	Herlev	Denmark	Recruiting