NCT07193017Not yet recruiting
The Effect of BIPAP on Diaphragmatic Function
The Effects of Biphasic Positive Airway Pressure (BIPAP) Use on Diaphragm Functions in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov · Last updated 25 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 10 Sept 2025
- Start date
- 15 Oct 2025
- Primary completion date
- 15 Oct 2026
- Lead sponsor
- Istanbul Demiroglu Bilim University
- Diseases
- COPD
- NCT number
- NCT07193017
What you commit to
- Study type: Observational
- Planned participants: 30
- From 15 Oct 2025 to the primary completion date, 15 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Long-term corticosteroid use,
- Chemotherapy,
- Thoracoabdominal surgery within the last 3 months.
Other illness
- Neuromuscular and neurological diseases,
- Decompensated heart failure,
- Active malignancy,
Other
- Pregnancy,
- Diaphragmatic paralysis,
- Chest deformity,
- Acute exacerbation within the last month,
- Pneumothorax,
- Body mass index greater than 35 kg/m²,
- Inability to cooperate,
Who the study is looking for
- 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,
- Having been initiated on BiPAP therapy with a clinical indication,
- Being willing to participate in the study and providing informed consent.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Demiroglu Bilim University, Department of Physiotherapy and Rehabilitation Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.