The Effect of BIPAP on Diaphragmatic Function

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Eligibility

Primary outcome measure(s)

• One-Year Survival — at baseline and after 12 months
  Survival status (alive or deceased) will be assessed at 12 months after initiation of BiPAP therapy. This will be recorded as a binary outcome.
• Number of Hospital Admissions within 12 Months — at baseline and after 12 months
  The number of hospital admissions due to respiratory or other causes will be recorded during the 12-month follow-up period. A higher number indicates greater healthcare utilization.
• Maximum Inspiratory Pressure (MIP) — Baseline, after 6 weeks of BiPAP usage, and after one year
  Respiratory muscle strength will be assessed using maximum inspiratory pressure (MIP), measured with a portable mouth pressure device according to standard guidelines. Higher values indicate better inspiratory muscle function.
• Maximum Expiratory Pressure (MEP) — At baseline, after 6 weeks of BiPAP usage, and after one year.
  Respiratory muscle strength will be assessed using maximum expiratory pressure (MEP), measured with a portable mouth pressure device according to standard guidelines. Higher values indicate better expiratory muscle function.
• Forced Vital Capacity (FVC) — Baseline, after 6 weeks of BiPAP usage, and after one year.
  Forced Vital Capacity (FVC) will be measured using a portable spirometer calibrated according to American Thoracic Society (ATS) and European Respiratory Society (ERS) standards. The best result from at least three attempts will be recorded.
• Forced Expiratory Volume in 1 Second (FEV₁) — Baseline, after 6 weeks of BiPAP usage, and after one year.
  Forced Expiratory Volume in 1 second (FEV₁) will be measured using a portable spirometer calibrated according to ATS/ERS standards. The best result from at least three attempts will be recorded.
• FEV₁/FVC Ratio — Baseline, after 6 weeks of BiPAP usage, and after one year.
  FEV₁/FVC ratio will be calculated from spirometry results. The best result from at least three attempts will be recorded.
• Cough Strength (Peak Cough Flow, PCF) — Baseline, after 6 weeks of BiPAP usage, and after one year.
  Peak Cough Flow (PCF) will be measured using a peak flow meter.
• Diaphragm Thickness (B-mode Ultrasound) — Baseline, after 6 weeks of BiPAP usage, and after one year.
  Diaphragm thickness will be measured in two-dimensional B-mode ultrasound from the right intercostal area (mid-axillary level), the right subcostal area (anterior axillary level and mid-clavicular level) with a superficial probe during deep inspiration and deep expiration.
• Diaphragm Excursion (M-mode Ultrasound) — Baseline, after 6 weeks of BiPAP usage, and after one year.
  Diaphragm mobility during normal inspiration and deep inspiration will be assessed using M-mode ultrasonography from the right subcostal area at the mid-axillary level.
• Diaphragmatic Tissue Velocity (Tissue Doppler Imaging) — Baseline, after 6 weeks of BiPAP usage, and after one year.
  Diaphragmatic tissue waveform and movement velocities during inspiration and expiration will be assessed using tissue Doppler ultrasonography. Maximum contraction and relaxation rates of the diaphragm will be recorded during 10 normal breaths.

Trial sites (1)

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