Clinical Trial

The Effect of BIPAP on Diaphragmatic Function

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Summary
This research is designed to evaluate how long-term treatment with Bilevel Positive Airway Pressure (BiPAP) influences diaphragm function in patients with Chronic Obstructive Pulmonary Disease (COPD) who suffer from chronic hypercapnic respiratory failure. The diaphragm is the primary muscle of breathing, and its dysfunction is linked to unfavorable clinical outcomes such as higher mortality rates and frequent hospitalizations. In this prospective cohort study, COPD patients starting BiPAP therapy based on clinical indication will be monitored through repeated ultrasound assessments of diaphragm structure and function together with pulmonary function testing, respiratory muscle strength evaluation, dyspnea. The main outcome of interest is the change in diaphragm thickness in inspiration, thickness in expiration, diaphragm thickening fraction (DTF), diaphragm maximum contraction velocity and maximum relaxation velocity across a 6 weeks as a early time and 12 months for long time follow-up period. Secondary measures include hospital admissions, and one-year survival. The study is expected to generate valuable evidence about the link between non-invasive ventilation and diaphragm function, which may contribute to optimizing treatment strategies for COPD patients with advanced respiratory failure.
Trial Details
NCT Number NCT07193017
Lead Sponsor Istanbul Demiroglu Bilim University
Collaborators: Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
Conditions BIPAP Biphasic Intermittent Positive Airway Pressure, Diaphragm Issues, Ultrasound Diagnostics, COPD (Chronic Obstructive Pulmonary Disease)
Enrollment 30 participants
Start Date 2025-10-15
Primary Completion 2026-10-15 (estimated)
Study Completion 2027-06-15 (estimated)
Updated on ClinicalTrials.gov 2025-09-25