Shear Wave Elastography of Intercostal Muscles for the Non-invasive Assessment of the Work of BreathinG
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGroupe Hospitalier du Havre
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Intercostal muscle shear wave elastography (SWE) during standardized inspiratory loading
Diagnostic testUltrasound 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Healthy adults1 intervention
Group B: COPD group1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
During a single study visit (≈45 minutes), at rest and at each standardized inspiratory load levelSecondary 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.
Time frame
Single study visit: during the inspiratory loading protocol (no resistance, then 25%, 50%, and 75% of maximal inspiratory pressure [PiMax])Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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