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Recruiting NCT07189260

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

No phase Interventional Hip Fractures (ICD-10 72.01-72.2)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: positive expiratory pressure.
Who it may be relevant to
Registry conditions: Hip Fractures (ICD-10 72.01-72.2). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Device positive expiratory pressure
    PEP therapy

Primary outcome measures

  • The incidence of hospital-acquired pneumonia [Time frame: During hospitalization, from intervention start to discharge, which is on average one week]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Denmark · 2 centers
  • Bispebjerg & Frederiksberg Hospital — Copenhagen
  • Herlev & Gentofte Hospital — Herlev

Identifiers

NCT: NCT07189260 · PEP trial

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗