Shear Wave Elastography of Peripheral Nerves for Early Diagnosis of ICU-acquired Weakness

Официальное название

Clinical Value of Shear Wave Elastography of Peripheral Nerves for the Early Diagnosis of ICU-Acquired Weakness: A Prospective Observational Pilot Study

Обзор

This study aims to determine whether shear wave elastography (SWE), a non-invasive ultrasound technique that measures nerve stiffness, can help detect ICU-acquired weakness (ICU-AW) early in critically ill patients. Adults receiving mechanical ventilation in the ICU will undergo ultrasound examinations of the median and tibial nerves on Days 1, 4, and 7. The study will evaluate whether early changes in nerve elasticity can predict ICU-AW, which is usually diagnosed later using a muscle strength score that requires patient cooperation.

Подробное описание

Intensive Care Unit-Acquired Weakness (ICU-AW) is a common and severe complication in critically ill patients, associated with poor long-term outcomes. The current gold standard for diagnosis, the Medical Research Council (MRC) score, requires patient cooperation and is often delayed.

Shear Wave Elastography (SWE) is an advanced ultrasound technique that quantitatively measures tissue stiffness. Pathophysiological changes in ICU-AW, such as axonal degeneration and edema in nerves, are expected to alter their biomechanical properties (elasticity). This study posits that these changes may be detectable early using SWE, preceding overt clinical weakness.

This study will prospectively enroll adult patients admitted to the ICU who are expected to require prolonged mechanical ventilation. Participants will undergo serial ultrasound examinations of the median and tibial nerves on days 1, 4, and 7 of their ICU stay. The examinations will include SWE to measure nerve elasticity (stiffness) and conventional B-mode ultrasound to measure nerve cross-sectional area (CSA).

On day 7, all consenting and cooperative patients will be assessed for ICU-AW using the MRC score. The primary objective is to determine the diagnostic accuracy of early nerve SWE measurements for predicting the diagnosis of ICU-AW on Day 7. Secondary objectives include describing the dynamic changes in nerve elasticity and size over the first week, and exploring the correlation between these ultrasound parameters and clinical severity scores and patient outcomes.

Вмешательства

• Диагностический тест Nerve Ultrasound with Shear Wave Elastography
  Patients will undergo non-invasive ultrasound examinations of the median nerve and tibial nerve at the bedside on days 1, 4, and 7. The examination includes Shear Wave Elastography (SWE) to quantify nerve stiffness (elasticity) and B-mode imaging to measure nerve cross-sectional area (CSA). This is a purely observational procedure and does not alter patient management.

Первичные конечные точки

• Diagnostic Accuracy of Nerve SWE on Day 1 for Predicting ICU-AW on Day 7 [Срок оценки: Day 1 and Day 7 after ICU admission]
• Diagnostic Accuracy of Nerve SWE on Day 4 for Predicting ICU-AW on Day 7 [Срок оценки: Day 4 and Day 7 after ICU admission]
• Diagnostic Accuracy of Nerve SWE on Day 7 for Diagnosing ICU-AW on Day 7 [Срок оценки: Day 7 after ICU admission]

Вторичные конечные точки (2)

• Change in Nerve Elasticity [Срок оценки: Day 1 to Day 7 after ICU admission]
• Correlation between Nerve Elasticity and Disease Severity [Срок оценки: Day 7]

Критерии участия

Критерии включения

• Age ≥ 18 years;
• Newly admitted to ICU with an expected ICU stay > 7 days;
• Initiated on mechanical ventilation within 24 hours of admission, with an expected ventilation duration > 48 hours;
• Patient or legally authorized representative provides written informed consent.

Критерии исключения

• Known pre-existing neuromuscular diseases (e.g., myasthenia gravis, Guillain-Barré syndrome, amyotrophic lateral sclerosis);
• Pre-existing limb dysfunction that would interfere with muscle strength assessment (e.g., hemiplegia, paraplegia, severe arthritis);
• Presence of acute trauma, surgery, skin breakdown, infection, or severe edema at the measurement sites (wrist, elbow, ankle) that would interfere with ultrasound probe placement;
• Pregnant or lactating women;
• Any other condition that the investigator believes would make the patient unsuitable for the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medic — Wuhu

Идентификаторы

NCT: NCT07594249 · 2026-ICU01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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