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NCT07193017

The Effect of BIPAP on Diaphragmatic Function

Sponsor: Istanbul Demiroglu Bilim University

View on ClinicalTrials.gov

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.

Official title: The Effects of Biphasic Positive Airway Pressure (BIPAP) Use on Diaphragm Functions in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2025-10-15

Completion Date

2027-06-15

Last Updated

2025-09-25

Healthy Volunteers

No

Interventions

DEVICE

BIPAP

After BIPAP Prescribed By A Physician, Diaphragmatic Functions Will Be Evaluated With Ultrasound In The Early And Late Periods

Locations (1)

Demiroglu Bilim University, Department of Physiotherapy and Rehabilitation

Istanbul, Turkey (Türkiye)