The University Hospital Bispebjerg and Frederiksberg is actively recruiting participants for a groundbreaking clinical trial focusing on the use of positive expiratory pressure (PEP) devices as part of pre- and postoperative chest therapy to reduce hospital-acquired pneumonia (HAP) in patients recovering from hip fractures. This trial marks a significant step forward in medical device innovation for postoperative care.
What is the aim of the study?
This trial investigates the effectiveness of delivering positive expiratory pressure therapy before and after surgery to lessen the risk of hospital-acquired pneumonia. Patients with hip fractures (classified under ICD-10 codes 72.01 through 72.2) are the target demographic, as they are particularly vulnerable to respiratory complications during hospitalization. The primary goal is to enhance recovery outcomes and reduce hospital costs tied to prolonged stays and respiratory issues.
How does the PEP device work?
Positive expiratory pressure devices are non-invasive tools designed to support better lung function. By creating resistance during exhalation, these devices help maintain open airways and facilitate mucus clearance. Typically used in respiratory therapy, their application is being explored in the perioperative setting to prevent conditions such as pneumonia. Manufacturers and clinical teams anticipate this device will greatly improve patient safety and clinical outcomes.
Why is this trial clinically important?
Hospital-acquired pneumonia remains a major concern, increasing morbidity and mortality rates following orthopedic surgeries. This trial could pave the way for adopting PEP therapy as a routine care protocol for hip fracture patients globally. If successful, the findings may inform updates to regulatory guidelines surrounding perioperative care devices and interventions. Such advancements reinforce the importance of integrating medical devices into holistic healthcare strategies.
FAQ
1. Who is eligible for this study?
Eligibility is focused on patients diagnosed with hip fractures categorized under ICD-10 codes 72.01 to 72.2.
2. What benefits are expected?
Potential benefits include lower pneumonia rates, better lung function, and shorter hospital stays for participants.
3. Where can I learn more?
Details about this study, including recruitment status, are available at the ClinicalTrials.gov listing linked below.
Conclusion
Positive expiratory pressure therapy could redefine postoperative care for hip fracture patients, offering evidence-based solutions to critical complications like hospital-acquired pneumonia. Professionals in clinical and regulatory fields should stay informed about this trial’s progress, as the findings may significantly influence orthopedic recovery protocols.
Disclaimer
The content presented is for informational purposes only and is not intended as legal or medical advice. Always consult relevant professionals for guidance on regulatory compliance or clinical applications.
Announcement Link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07189260?term=medical+device