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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Bispebjerg and Frederiksberg

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hip fracture regardless of age

Cognitively well-functioning

Able to understand the study and give informed consent

Able to speak and understand Danish

Disqualifiers

Cognitively impaired

Unable to understand the study and give informed consent

Pneumonia upon admission

Delirium upon admission

Trial design

Design model

Parallel

Treatments tested in this trial

  • positive expiratory pressure

    Device

    PEP therapy

Treatment groups

566 Participants
are divided into 2 treatment groups
Group A: ActiveActive comparator 1 intervention
Group B: Standard treatmentNo intervention 0 interventions

Trial outcomes

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

Time frame
During hospitalization, from intervention start to discharge, which is on average one week

Secondary outcomes

1

Number of participants dead within 30-days after discharge

Number of participants dead within 30 days after discharge

Time frame
30-day mortality, assessed 30 days after discharge from the orthopedic ward
2

Number of participants readmitted within 30-days after discharge

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
3

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

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
4

Degree of regained basic mobility (Cumulated Ambulation Score - CAS) on the the day of discharge compared to the assement made at 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.

Time frame
CAS the weeks up to hip fracture and CAS at discharge, which is on average one week after admission

Other outcomes

Sponsors and contacts

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