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| Name | Class |
|---|---|
| Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital | OTHER |
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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.
Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory condition frequently complicated by chronic hypercapnic respiratory failure. In this population, long-term non-invasive ventilation with bilevel positive airway pressure (BiPAP) is widely prescribed to improve gas exchange, relieve symptoms, and reduce the risk of hospitalizations. However, its effects on diaphragm function, the main respiratory muscle, remain poorly understood. Diaphragm dysfunction in COPD has been associated with adverse outcomes including increased mortality, prolonged hospital stay, and higher readmission rates.
This prospective cohort study aims to evaluate the longitudinal impact of BiPAP treatment on diaphragm structure and function in patients with COPD and chronic hypercapnic respiratory failure. Eligible participants will be patients who are prescribed BiPAP therapy according to standard clinical indications. Diaphragm function will be assessed repeatedly using ultrasonography, which provides non-invasive and reliable measurements of diaphragm thickness at end-inspiration and end-expiration, thickening fraction (DTF), maximum contraction velocity, and maximum relaxation velocity. These measurements will be complemented by pulmonary function tests, respiratory muscle strength evaluations, and dyspnea assessment.
The primary outcome is the change in diaphragm ultrasound parameters (inspiratory thickness, expiratory thickness, thickening fraction, contraction velocity, and relaxation velocity) over the course of treatment. Early follow-up will occur at 6 weeks to assess short-term effects, while long-term follow-up at 12 months will provide insight into sustained adaptations to BiPAP therapy. Secondary outcomes include the frequency of hospital admissions and overall one-year survival.
By integrating functional, structural, and clinical outcomes, the study is expected to provide novel evidence on the role of non-invasive ventilation in modifying diaphragm performance. Findings may contribute to refining treatment strategies and optimizing long-term management of COPD patients with advanced respiratory failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| copd patients | Patients diagnosed with chronic obstructive pulmonary disease (COPD) who have been prescribed BiPAP therapy by a physician. Participants will undergo diaphragmatic function evaluations with ultrasound at baseline, after 6 weeks of BiPAP usage, and after one year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIPAP | Device | After BIPAP Prescribed By A Physician, Diaphragmatic Functions Will Be Evaluated With Ultrasound In The Early And Late Periods |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at baseline and after 12 months |
| 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. | at baseline and after 12 months |
| 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. | Baseline, after 6 weeks of BiPAP usage, and after one year |
| 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. | At baseline, after 6 weeks of BiPAP usage, and after one year. |
| Forced Vital Capacity (FVC) | 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. | Baseline, after 6 weeks of BiPAP usage, and after one year. |
| Forced Expiratory Volume in 1 Second (FEV₁) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at baseline and after 6 weeks of BIPAP usage and after one year |
| Dyspnea (mMRC Scale) |
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Inclusion Criteria:
Exclusion Criteria:
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COPD patient prescribed BIPAP
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reyhan Kaygusuz Benli, Asst Prof | Contact | +90 553 3057467 | reyhan.kaygusuz@demiroglu.bilim.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Reyhan Kaygusuz Benli, Asst Prof | Demiroglu Bilim University, Dept. of Physiotherapy and Rehabilitation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Demiroglu Bilim University, Department of Physiotherapy and Rehabilitation | Istanbul | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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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.
| Baseline, after 6 weeks of BiPAP usage, and after one year. |
| FEV₁/FVC Ratio | FEV₁/FVC ratio will be calculated from spirometry results. The best result from at least three attempts will be recorded. | Baseline, after 6 weeks of BiPAP usage, and after one year. |
| Cough Strength (Peak Cough Flow, PCF) | Peak Cough Flow (PCF) will be measured using a peak flow meter. | Baseline, after 6 weeks of BiPAP usage, and after one year. |
| Diaphragm Thickness (B-mode Ultrasound) | 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. | Baseline, after 6 weeks of BiPAP usage, and after one year. |
| Diaphragm Excursion (M-mode Ultrasound) | 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. | Baseline, after 6 weeks of BiPAP usage, and after one year. |
| Diaphragmatic Tissue Velocity (Tissue Doppler Imaging) | 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. | Baseline, after 6 weeks of BiPAP usage, and after one year. |
Dyspnea severity will be evaluated using the modified Medical Research Council (mMRC) dyspnea scale, ranging from 0 (no dyspnea) to 4 (severe dyspnea). |
| at baseline and after 6 weeks of BIPAP usage and after one year |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |