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.
Being between 40-80 years of age,
Having a diagnosis of stable COPD for at least 1 year,
Being in a stable phase (no acute exacerbation within the last 4 weeks),
Meeting the GOLD 2025 A-B-E classification according to symptoms and exacerbation history,
Pregnancy,
Diaphragmatic paralysis,
Neuromuscular and neurological diseases,
Decompensated heart failure,
COPD patient prescribed BIPAP
Cohort
Prospective
BIPAP
DeviceAfter BIPAP Prescribed By A Physician, Diaphragmatic Functions Will Be Evaluated With Ultrasound In The Early And Late Periods
One-Year Survival
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
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)
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)
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.
COPD Assessment Test (CAT) Score:
CAT will be used to assess health status impairment in patients with respiratory symptoms. Higher scores indicate greater symptom burden.
Dyspnea (mMRC Scale)
Dyspnea severity will be evaluated using the modified Medical Research Council (mMRC) dyspnea scale, ranging from 0 (no dyspnea) to 4 (severe dyspnea).
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Istanbul Demiroglu Bilim University
Lead sponsor
Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
Collaborator
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