The Effect of BIPAP on Diaphragmatic Function

NCT07193017 | Not Yet Recruiting

• 1 other identifier: Effect of BIPAP on diaphragm
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

bıpap, diaphragm function, diaphragm ultrasound, copy

Outcome Measures

Primary Outcomes (11)

• 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)

  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.

Secondary Outcomes (2)

• COPD Assessment Test (CAT) Score:

  at baseline and after 6 weeks of BIPAP usage and after one year

• Dyspnea (mMRC Scale)

  at baseline and after 6 weeks of BIPAP usage and after one year

Study Arms (1)

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.

Device: BIPAP

Interventions

BIPAP DEVICE

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

copd patients

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

COPD patient prescribed BIPAP

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy,
• Diaphragmatic paralysis,
• Neuromuscular and neurological diseases,
• Decompensated heart failure,
• Chest deformity,
• Acute exacerbation within the last month,
• Pneumothorax,
• Body mass index greater than 35 kg/m²,
• Long-term corticosteroid use,
• Chemotherapy,
• Active malignancy,
• Inability to cooperate,
• Thoracoabdominal surgery within the last 3 months.

Sponsors & Collaborators

• Istanbul Demiroglu Bilim University: lead
• Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital: collaborator

Study Sites (1)

Demiroglu Bilim University, Department of Physiotherapy and Rehabilitation

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Reyhan Kaygusuz Benli, Asst Prof

  Demiroglu Bilim University, Dept. of Physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reyhan Kaygusuz Benli, Asst Prof

CONTACT

+90 553 3057467; reyhan.kaygusuz@demiroglu.bilim.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 25, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): June 15, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)