BIPAP Biphasic Intermittent Positive Airway PressureNCT07193017
The Effect of BIPAP on Diaphragmatic Function
An observational study of BIPAP Biphasic Intermittent Positive Airway Pressure and Diaphragm Issues, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- BIPAP Biphasic Intermittent Positive Airway Pressure, Diaphragm Issues, Ultrasound Diagnostics
- What is being tested?
- BIPAP
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2025to 15 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patient prescribed BIPAP
Who may be able to join
- 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.
Who cannot join
- Pregnancy,
- Diaphragmatic paralysis,
- Neuromuscular and neurological diseases,
- Decompensated heart failure,
- Chest deformity,
- Acute exacerbation within the last month,
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Demiroglu Bilim University, Department of Physiotherapy and Rehabilitation
Istanbul
Reyhan Kaygusuz Benli Principal Investigator, Asst Prof, +905533057467
About this study
Official title: The Effects of Biphasic Positive Airway Pressure (BIPAP) Use on Diaphragm Functions in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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.
Read the detailed description
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.
- Conditions
- BIPAP Biphasic Intermittent Positive Airway Pressure, Diaphragm Issues, Ultrasound Diagnostics, COPD (Chronic Obstructive Pulmonary Disease)
- Being tested
- BIPAP
- Keywords
- bıpap, diaphragm function, diaphragm ultrasound, copy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIPAPDevice
After BIPAP Prescribed By A Physician, Diaphragmatic Functions Will Be Evaluated With Ultrasound In The Early And Late Periods
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: BIPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, after 6 weeks of BiPAP usage, and after one year.
Secondary outcomes (2)
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.
Measured: at baseline and after 6 weeks of BIPAP usage and after one year
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).
Measured: at baseline and after 6 weeks of BIPAP usage and after one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start15 Oct 2025 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BIPAP Biphasic Intermittent Positive Airway PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Demiroglu Bilim University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
- Responsible party
- Principal investigator, Reyhan Kaygusuz, Istanbul Demiroglu Bilim University
- Investigators
- Reyhan Kaygusuz Benli, Asst Prof, Principal investigator, Demiroglu Bilim University, Dept. of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193017
- Sponsor's protocol ID
- Effect of BIPAP on diaphragm
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Biphasic Positive Airway Pressure (BIPAP) Use on Diaphragm Functions in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT07193017
- Acronym / sponsor ID
- Effect of BIPAP on diaphragm
- Conditions
- BIPAP Biphasic Intermittent Positive Airway Pressure, Diaphragm Issues, Ultrasound Diagnostics, COPD (Chronic Obstructive Pulmonary Disease)
- Keywords
- bıpap, diaphragm function, diaphragm ultrasound, copy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul Demiroglu Bilim UniversityUniversity, hospital or other
- Collaborators
- Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| copd patients | – | Device: BIPAPPatients 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patient prescribed BIPAP
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (13 listed)
- Pregnancy,
- Diaphragmatic paralysis,
- Neuromuscular and neurological diseases,
- Decompensated heart failure,
- Chest deformity,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIPAPAfter BIPAP Prescribed By A Physician, Diaphragmatic Functions Will Be Evaluated With Ultrasound In The Early And Late Periods | Device | copd patients |
Primary outcome
One-Year Survival
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
COPD Assessment Test (CAT) Score:
Time frame: at baseline and after 6 weeks of BIPAP usage and after one year
Dyspnea (mMRC Scale)
Time frame: at baseline and after 6 weeks of BIPAP usage and after one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reyhan Kaygusuz Benli, Asst Prof principal investigator
Demiroglu Bilim University, Dept. of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BIPAP Biphasic Intermittent Positive Airway Pressure and Diaphragm Issues, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reyhan Kaygusuz Benli, Asst Prof (+90 553 3057467, reyhan.kaygusuz@demiroglu.bilim.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-Year Survival (time frame: at baseline and after 12 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.