COPDSWINGNCT07371754
Shear Wave Elastography of Intercostal Muscles for the Non-invasive Assessment of the Work of BreathinG
An observational study of COPD and Healthy Adult, run by Groupe Hospitalier du Havre.
Trial summary
Quantifying respiratory effort is a key step in physiological and clinical research on exercise tolerance, mechanisms of fatigability, and ventilatory impairment. To date, reliable assessment relies on an invasive method: esophageal pressure (Pes) measurement using a balloon catheter inserted into the esophagus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD, Healthy Adult
- What is being tested?
- Intercostal muscle shear wave elastography (SWE) during standardized inspiratory loading
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Mar 2027
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults (≥18 years) will be enrolled in two cohorts: (1) healthy adult volunteers and (2) adult patients with chronic obstructive pulmonary disease (COPD), stage 3-4. A total of 20 participants will be recruited (10 COPD patients and 10 healthy volunteers). Each participant will complete a single study visit (~45 minutes) involving standardized breathing/inspiratory loading while intercostal muscle ultrasound shear wave elastography is recorded, with concurrent physiological reference measurements to quantify respiratory effort.
Who may be able to join
- Adult patient with chronic obstructive pulmonary disease (COPD), stage 3-4.
- Healthy adult volunteer.
Who cannot join
- Refusal to participate or withdrawal of consent.
- Age < 18 years.
- BMI > 35 kg/m².
- Pregnancy or breastfeeding.
- Inability to understand instructions or cooperate (cognitive impairment, language barrier).
- Neurological condition affecting breathing (e.g., recent stroke, ALS, myopathy).
Show all 16Show fewer
- Thoracic condition limiting access to the intercostal muscles (e.g., major chest wall deformity, surgical scar).
- Recent thoracic or abdominal surgery (< 3 months).
- Known esophageal disease (stricture, achalasia, severe esophagitis, diverticulum, history of perforation).
- ENT or tracheal abnormality preventing probe insertion (e.g., tumor, malformation, tracheostomy).
- Swallowing disorders or risk of aspiration.
- Recent exacerbation (< 6 weeks).
- Oxygen therapy > 2 L/min during exertion.
- Hemodynamic instability.
- Not affiliated with a social security scheme.
- Legally protected persons (as defined by law).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Angélique Picard contact
About this study
Quantifying respiratory effort is a key step in physiological and clinical research on exercise tolerance, mechanisms of fatigability, and ventilatory impairment. To date, reliable assessment relies on an invasive method: esophageal pressure (Pes) measurement using a balloon catheter inserted into the esophagus. Although Pes provides an indirect estimate of pleural and intrathoracic pressure, it is uncomfortable for patients, requires dedicated equipment, and may limit study participation.
In critically ill patients, a noninvasive approach to quantify respiratory effort would have major clinical and scientific value. In acute respiratory distress, accurately tracking the intensity and evolution of respiratory effort could support earlier therapeutic decision-making.
Shear Wave Elastography (SWE) is an ultrasound technology enabling very high acquisition rates and estimating tissue stiffness from shear-wave propagation induced by an acoustic impulse. Because muscle stiffness is strongly related to force produced during contraction, we hypothesize that intercostal muscle stiffness measured by SWE correlates with respiratory work and increases with rising inspiratory load.
- Conditions
- COPD, Healthy Adult
- Being tested
- Intercostal muscle shear wave elastography (SWE) during standardized inspiratory loading
- Keywords
- Shear wave elastography, Intercostal muscles, work of breathing
- 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.
Intercostal muscle shear wave elastography (SWE) during standardized inspiratory loadingDiagnostic test
Also called Ultrasound shear wave elastography of intercostal muscles
Ultrasound shear wave elastography (SWE) is performed to quantify intercostal muscle stiffness at rest and during standardized inspiratory loading/controlled breathing. SWE acquisitions are synchronized with physiological reference recordings (e.g., esophageal pressure and/or diaphragm EMG when available) to estimate and track respiratory effort/work noninvasively.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Participant without respiratory, muscle or thoracic abnormalities Receives: Diagnostic Test: Intercostal muscle shear wave elastography (SWE) during standardized inspiratory loading | |
| COPD group | Patients with COPD Receives: Diagnostic Test: Intercostal muscle shear wave elastography (SWE) during standardized inspiratory loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between intercostal muscle stiffness (SWE) and respiratory effort (esophageal pressure-time product)
Intercostal muscle stiffness (kPa) measured by shear wave elastography is correlated with respiratory effort quantified by the esophageal pressure-time product (PTPes; cmH2O·s/min) across the standardized inspiratory loading protocol (within each cohort).
Measured: During a single study visit (≈45 minutes), at rest and at each standardized inspiratory load level
Secondary outcomes (1)
Within-subject change in intercostal muscle stiffness (SWE) across inspiratory load levels
Intercostal muscle stiffness (kPa) measured by shear wave elastography (SWE) will be assessed within participants across the different inspiratory load levels.
Measured: Single study visit: during the inspiratory loading protocol (no resistance, then 25%, 50%, and 75% of maximal inspiratory pressure [PiMax])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- 20 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier du Havre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371754
- Sponsor's protocol ID
- 2025-A01528-41
- Acronym
- SWING
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be made available upon reasonable request. Requests will be reviewed on a case-by-case basis and, if approved, de-identified data and relevant documentation (e.g., protocol and data dictionary) will be shared under an appropriate data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shear Wave Elastography of Intercostal Muscles for the Non-invasive Assessment of the Work of BreathinG
- ClinicalTrials.gov ID
- NCT07371754
- Acronym / sponsor ID
- SWING / 2025-A01528-41
- Conditions
- COPD, Healthy Adult
- Keywords
- Shear wave elastography, Intercostal muscles, work of breathing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Groupe Hospitalier du HavreUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 28 Jan 2026 (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.
Quantifying respiratory effort is a key step in physiological and clinical research on exercise tolerance, mechanisms of fatigability, and ventilatory impairment. To date, reliable assessment relies on an invasive method: esophageal pressure (Pes) measurement using a balloon catheter inserted into the esophagus. Although Pes provides an indirect estimate of pleural and intrathoracic pressure, it is uncomfortable for patients, requires dedicated equipment, and may limit study participation.
In critically ill patients, a noninvasive approach to quantify respiratory effort would have major clinical and scientific value. In acute respiratory distress, accurately tracking the intensity and evolution of respiratory effort could support earlier therapeutic decision-making.
Shear Wave Elastography (SWE) is an ultrasound technology enabling very high acquisition rates and estimating tissue stiffness from shear-wave propagation induced by an acoustic impulse. Because muscle stiffness is strongly related to force produced during contraction, we hypothesize that intercostal muscle stiffness measured by SWE correlates with respiratory work and increases with rising inspiratory load.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | Diagnostic Test: Intercostal muscle shear wave elastography (SWE) during standardized inspiratory loadingParticipant without respiratory, muscle or thoracic abnormalities |
| COPD group | – | Diagnostic Test: Intercostal muscle shear wave elastography (SWE) during standardized inspiratory loadingPatients with COPD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥18 years) will be enrolled in two cohorts: (1) healthy adult volunteers and (2) adult patients with chronic obstructive pulmonary disease (COPD), stage 3-4. A total of 20 participants will be recruited (10 COPD patients and 10 healthy volunteers). Each participant will complete a single study visit (~45 minutes) involving standardized breathing/inspiratory loading while intercostal muscle ultrasound shear wave elastography is recorded, with concurrent physiological reference measurements to quantify respiratory effort.
Key inclusion criteria (2 listed)
- Adult patient with chronic obstructive pulmonary disease (COPD), stage 3-4.
- Healthy adult volunteer.
Key exclusion criteria (16 listed)
- Refusal to participate or withdrawal of consent.
- Age < 18 years.
- BMI > 35 kg/m².
- Pregnancy or breastfeeding.
- Inability to understand instructions or cooperate (cognitive impairment, language barrier).
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 |
|---|---|---|
| Intercostal muscle shear wave elastography (SWE) during standardized inspiratory loadingAlso: Ultrasound shear wave elastography of intercostal musclesUltrasound shear wave elastography (SWE) is performed to quantify intercostal muscle stiffness at rest and during standardized inspiratory loading/controlled breathing. SWE acquisitions are synchronized with physiological reference recordings (e.g., esophageal pressure and/or diaphragm EMG when available) to estimate and track respiratory effort/work noninvasively. | Diagnostic test | COPD group, Healthy adults |
Primary outcome
Correlation between intercostal muscle stiffness (SWE) and respiratory effort (esophageal pressure-time product)
Time frame: During a single study visit (≈45 minutes), at rest and at each standardized inspiratory load level
Intercostal muscle stiffness (kPa) measured by shear wave elastography is correlated with respiratory effort quantified by the esophageal pressure-time product (PTPes; cmH2O·s/min) across the standardized inspiratory loading protocol (within each cohort).
1 secondary outcome
Within-subject change in intercostal muscle stiffness (SWE) across inspiratory load levels
Time frame: Single study visit: during the inspiratory loading protocol (no resistance, then 25%, 50%, and 75% of maximal inspiratory pressure [PiMax])
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 28 Jan 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be made available upon reasonable request. Requests will be reviewed on a case-by-case basis and, if approved, de-identified data and relevant documentation (e.g., protocol and data dictionary) will be shared under an appropriate data use agreement.
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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.
Angélique Picard contact
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Healthy Adult, run by Groupe Hospitalier du Havre.
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 2 inclusion and 16 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 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Clément Medrinal (+33664615110, medrinal.clement.mk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between intercostal muscle stiffness (SWE) and respiratory effort (esophageal pressure-time product) (time frame: During a single study visit (≈45 minutes), at rest and at each standardized inspiratory load level). 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 28 Jan 2026.