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NCT Number: NCT07189260

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

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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Key information

Conditions

Hip Fractures (ICD-10 72.01-72.2) Bone Diseases Bone Diseases, Metabolic Cross Infection Disease Attributes Femoral Fractures Fractures, Bone Frailty Healthcare-Associated Pneumonia Hip Fractures Hip Injuries Iatrogenic Disease Infections Leg Injuries Lung Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg & Frederiksberg Hospital, Copenhagen, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Positive expiratory pressure

Device

PEP therapy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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 dead within 30 days after discharge

  2. 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

    Number of participants readmitted within 30 days after discharge

  3. 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

    Incidence of delirium during hospitalization (journal entry, CAM-screening, diagnosis), up to 4 weeks.

  4. 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

    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.

  5. 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

    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.

Sponsors and collaborators

Lead sponsor

University Hospital Bispebjerg and Frederiksberg

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Sep 23, 2025
Registry last updated
Sep 23, 2025

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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