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

NCT ID: NCT07189260

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

566 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-19

Study Completion Date

2030-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Fractures (ICD-10 72.01-72.2)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active

Medical therapy device

Group Type ACTIVE_COMPARATOR

positive expiratory pressure

Intervention Type DEVICE

PEP therapy

Standard treatment

Standard treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

positive expiratory pressure

PEP therapy

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital Bispebjerg and Frederiksberg

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Charlotte Densing

Project nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bispebjerg & Frederiksberg Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Herlev & Gentofte Hospital

Herlev, , Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ditte Stensgaard Andreasen

Role: primary

+4521283123

Charlotte Densing Petersen

Role: backup

Camilla Paaske

Role: primary

+4538689682

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PEP trial

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Better Hips- Better Function
NCT02815254 COMPLETED NA