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NCT Number: NCT07371754

Shear Wave Elastography of Intercostal Muscles for the Non-invasive Assessment of the Work of BreathinG

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patient with chronic obstructive pulmonary disease (COPD), stage 3-4.

Healthy adult volunteer.

Exclusion criteria

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).

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.

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Legally protected persons (as defined by law).

Treatment and study plan

Intercostal muscle shear wave elastography (SWE) during standardized inspiratory loading

Diagnostic Test

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.

Other names: Ultrasound shear wave elastography of intercostal muscles

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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])

    Intercostal muscle stiffness (kPa) measured by shear wave elastography (SWE) will be assessed within participants across the different inspiratory load levels.

Study contacts

Contact information is provided by the study sponsor or research team.

Angélique Picard

CONTACT

[email protected]

Clément Medrinal

CONTACT

[email protected]

+33664615110

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier du Havre

Other

Registry information

Acronym: SWING

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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