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The Effect of BIPAP on Diaphragmatic Function

NCT07193017 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-09-25

No results posted yet for this study

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.

Conditions

  • BIPAP Biphasic Intermittent Positive Airway Pressure
  • Diaphragm Issues
  • Ultrasound Diagnostics
  • COPD (Chronic Obstructive Pulmonary Disease)

Interventions

DEVICE

BIPAP

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

Sponsors & Collaborators

  • Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital

    collaborator OTHER

  • Istanbul Demiroglu Bilim University

    lead OTHER

Principal Investigators

  • Reyhan Kaygusuz Benli, Asst Prof · Demiroglu Bilim University, Dept. of Physiotherapy and Rehabilitation

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-15
Primary Completion
2026-10-15
Completion
2027-06-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07193017 on ClinicalTrials.gov