Shear Wave Elastography of Intercostal Muscles for the Non-invasive Assessment of the Work of BreathinG
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Correlation between intercostal muscle stiffness (SWE) and respiratory effort (esophageal pressure-time product)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patient with chronic obstructive pulmonary disease (COPD), stage 3-
- •Healthy adult volunteer.
排除标准
- •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).
研究组 & 干预措施
Healthy adults
Participant without respiratory, muscle or thoracic abnormalities
干预措施: Intercostal muscle shear wave elastography (SWE) during standardized inspiratory loading (Diagnostic Test)
COPD group
Patients with COPD
干预措施: Intercostal muscle shear wave elastography (SWE) during standardized inspiratory loading (Diagnostic Test)
结局指标
主要结局
Correlation between intercostal muscle stiffness (SWE) and respiratory effort (esophageal pressure-time product)
时间窗: 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).
次要结局
- Within-subject change in intercostal muscle stiffness (SWE) across inspiratory load levels(Single study visit: during the inspiratory loading protocol (no resistance, then 25%, 50%, and 75% of maximal inspiratory pressure [PiMax]))