Skip to content

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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07189260
Enrollment
566
Registered
2025-09-23
Start date
2024-02-19
Completion date
2030-12-31
Last updated
2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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, frailty, multimorbidity

Brief 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.

Interventions

Sponsors

University Hospital Bispebjerg and Frederiksberg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The incidence of hospital-acquired pneumoniaDuring hospitalization, from intervention start to discharge, which is on average one weekPrimary 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

MeasureTime frameDescription
Number of participants dead within 30-days after discharge30-day mortality, assessed 30 days after discharge from the orthopedic wardNumber of participants dead within 30 days after discharge
Number of participants readmitted within 30-days after discharge30-day readmission post-discharge, assessed 30 days after discharge from the orthopedic wardNumber 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 weekIncidence 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 admissionDegree 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 admissionDischarge 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026