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

NCT07189260 | Recruiting

• 1 other identifier: PEP trial
• Study Type: interventional
• Target: 566
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  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

  30-day mortality, assessed 30 days after discharge from the orthopedic ward

• Number of participants readmitted within 30-days after discharge

  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.

  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.

  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.

  Assessed at discharge from the orthopedic department, which is on average one week efter admission

Study Arms (2)

Active

ACTIVE COMPARATOR

Medical therapy device

Device: positive expiratory pressure

Standard treatment

NO INTERVENTION

Standard treatment

Interventions

positive expiratory pressure DEVICE

PEP therapy

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (2)

Bispebjerg & Frederiksberg Hospital

Copenhagen, 2400, Denmark

RECRUITING

Herlev & Gentofte Hospital

Herlev, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Hip Fractures; Pneumonia; Healthcare-Associated Pneumonia; Osteoporosis; Frailty

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project nurse

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: September 23, 2025
• Study Start: February 19, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 23, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

DK (2)