A new clinical trial sponsored by Riphah International University is recruiting participants to explore the effects of innovative breathing techniques—Bubble Positive Expiratory Pressure (Bubble PEP) and segmental breathing—compared to traditional methods like incentive spirometry in managing pleural effusion, a condition involving fluid buildup around the lungs.
Regulatory, clinical, and quality teams involved in respiratory device evaluations or therapeutic interventions may find these findings impactful.
In this article:
- What changed?
- Clinical focus and investigational techniques
- Implications for stakeholders
- FAQ
- Conclusion
- Disclaimer
- Announcement details
What changed?
A clinical trial listed on ClinicalTrials.gov (ID: NCT07248774) is actively recruiting participants as of November 2025. This study is centered around pleural effusion treatment optimization using Bubble PEP, segmental breathing, and incentive spirometry. The interventions aim to improve respiratory muscle function, drainage effectiveness, and patient outcomes.
Clinical focus and investigational techniques
Understanding Bubble Positive Expiratory Pressure (Bubble PEP): Bubble PEP involves breathing through a tube submerged in water, creating resistance that enhances the recruitment of respiratory muscles and improves mucus clearance.
This innovative device technique is compared to segmental breathing exercises—focusing on localized lung expansion—and traditional incentive spirometry, which encourages patients to take deep breaths to open up airways and improve lung function.
Why pleural effusion treatment matters: Pleural effusion results from excess fluid accumulating between the layers around the lungs, often causing breathlessness, discomfort, and reduced pulmonary activity. Effective respiratory therapy interventions are critical to managing this condition and reducing patient burden.
The trial’s goal is to evaluate the therapeutic performance and safety of Bubble PEP and segmental breathing while also comparing their outcomes to established methods like incentive spirometry.
Implications for stakeholders
Regulatory insights: Manufacturers and quality teams involved in producing respiratory support devices may find tangible data from this trial to influence innovations, market applications, and device clearances.
Clinical implications: Healthcare providers managing pleural effusion may gain insights on optimal therapeutic tools and methods to integrate into respiratory care standards.
Data for Regulatory Bodies: Results of this study may provide key clinical evaluation data necessary for Medical Device Regulation (MDR), Annex XIV compliance concerning performance and safety assessments of respiratory tools used in pleural effusion treatment.
FAQ
- What is the purpose of the study?
To compare the effectiveness of Bubble PEP, segmental breathing exercises, and incentive spirometry for treating pleural effusion. - How do Bubble PEP and incentive spirometry differ?
Bubble PEP creates expiratory resistance via submerged tubing, focusing on mucus clearance, whereas incentive spirometry encourages deep breaths to open airways. - Is the study recruiting participants?
Yes, as of November 27, 2025, the trial is open for participant recruitment. - Where is the trial sponsored?
The study is sponsored by Riphah International University.
Conclusion
The ongoing clinical trial aims to improve therapeutic techniques for pleural effusion using innovative methods like Bubble PEP alongside comparative tools such as segmental breathing and incentive spirometry. Results may influence therapeutic design, regulatory compliance strategies, and clinical adoption of the studied interventions.
Disclaimer
This article presents general information based on the referenced clinical trial and is not intended as professional or legal advice. Stakeholders are encouraged to consult regulatory or legal experts.
Announcement details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07248774?term=medical+device