Publication Date: October 5, 2025
A new clinical trial spearheaded by Istanbul Demiroglu Bilim University and Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital is set to explore the impact of Biphasic Intermittent Positive Airway Pressure (BIPAP) therapy on diaphragmatic function. The study will employ advanced ultrasound diagnostics to assess changes in the diaphragm’s performance, focusing on potential applications for managing patients with Chronic Obstructive Pulmonary Disease (COPD). Recruitment for the trial is not yet open.
In this article:
- What is the purpose of this trial?
- Who will participate in the study?
- How will the trial be conducted?
- Frequently Asked Questions
- Conclusion
- Medical Disclaimer
- Announcement Link
What is the purpose of this trial?
This clinical research aims to evaluate the influence of BIPAP therapy on the functionality of the diaphragm, particularly in patients dealing with respiratory challenges. BIPAP is a well-known respiratory support device that provides varying levels of airway pressure for inhalation and exhalation. By leveraging ultrasound diagnostics, the trial seeks to produce quantifiable data on diaphragmatic movement and strength, providing critical insights into its therapeutic effects on COPD patients and others with related conditions.
Who will participate in the study?
The study will primarily target patients diagnosed with Chronic Obstructive Pulmonary Disease and individuals experiencing diaphragmatic dysfunction. Participants will be selected after meeting specific eligibility criteria designed to ensure the safety and reliability of the trial’s findings. At this stage, recruitment is not yet open; interested parties are encouraged to keep an eye on updates regarding participation requirements.
How will the trial be conducted?
The study will utilize a standardized BIPAP device as the main intervention, monitoring diaphragmatic activity over a specified period. Advanced ultrasound technology will be employed to measure parameters such as diaphragmatic excursion and thickness. The trial’s design includes a stringent regulatory framework to ensure compliance with international safety and ethical standards, adhering closely to Good Clinical Practice (GCP) guidelines. The findings are expected to help shape future guidance on integrating BIPAP therapy into clinical protocols for COPD management and other respiratory conditions.
Frequently Asked Questions
1. What is BIPAP?
BIPAP stands for Biphasic Intermittent Positive Airway Pressure. It is a medical device that supports breathing by providing variable pressures during inhalation and exhalation.
2. Is the trial currently recruiting?
No, recruitment has not yet opened for this trial. Updates will be provided when recruitment begins.
3. How is diaphragmatic function assessed?
The trial will use ultrasound technology to measure diaphragmatic movement and thickness, offering non-invasive insights into its function.
4. Who is sponsoring this research?
The study is sponsored by Istanbul Demiroglu Bilim University and Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital.
Conclusion
The upcoming clinical trial presents an exciting opportunity to better understand the therapeutic role of BIPAP in enhancing diaphragmatic function. Through state-of-the-art diagnostics, the study aims to generate evidence that could influence future respiratory care practices. Medical professionals, regulatory bodies, and stakeholders are encouraged to monitor the study’s progress closely for valuable insights into BIPAP’s clinical applications.
Medical Disclaimer
The information provided here is intended solely for healthcare professionals and regulatory stakeholders. It does not constitute legal or clinical advice. For detailed guidance, consult qualified experts in medical device regulations and clinical practices.
Announcement Link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07193017?term=medical+device