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

Обзор

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.

Вмешательства

• Диагностический тест Intercostal muscle shear wave elastography (SWE) during standardized inspiratory loading
  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.

Первичные конечные точки

• Correlation between intercostal muscle stiffness (SWE) and respiratory effort (esophageal pressure-time product) [Срок оценки: During a single study visit (≈45 minutes), at rest and at each standardized inspiratory load level]

Вторичные конечные точки (1)

• Within-subject change in intercostal muscle stiffness (SWE) across inspiratory load levels [Срок оценки: Single study visit: during the inspiratory loading protocol (no resistance, then 25%, 50%, and 75% of maximal inspiratory pressure [PiMax])]

Критерии участия

Критерии включения

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

Healthy adult volunteer.

Критерии исключения

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.

Not affiliated with a social security scheme.

Legally protected persons (as defined by law).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07371754 · 2025-A01528-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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