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

2026年6月13日 更新者：Qiancheng Xu、First Affiliated Hospital of Wannan Medical College

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

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (估计的)

98

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Anhui
      • Wuhu、Anhui、中国、241001
        • The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Critically ill adults on mechanical ventilation with an anticipated ICU stay greater than 7 days.

描述

Inclusion Criteria:

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

Exclusion Criteria:

  1. Known pre-existing neuromuscular diseases (e.g., myasthenia gravis, Guillain-Barré syndrome, amyotrophic lateral sclerosis);
  2. Pre-existing limb dysfunction that would interfere with muscle strength assessment (e.g., hemiplegia, paraplegia, severe arthritis);
  3. 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;
  4. Pregnant or lactating women;
  5. Any other condition that the investigator believes would make the patient unsuitable for the study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
ICU Patients on Mechanical Ventilation
A cohort of adult patients newly admitted to the ICU who are receiving mechanical ventilation and are at risk for developing ICU-Acquired Weakness.
诊断测试：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Diagnostic Accuracy of Nerve SWE on Day 1 for Predicting ICU-AW on Day 7
大体时间：Day 1 and Day 7 after ICU admission

Area Under the Receiver Operating Characteristic Curve (AUC) for the mean elasticity value (measured in kilopascals, kPa) of the median and tibial nerves, assessed separately at three time points after ICU admission:

Day 1 - to predict ICU-AW diagnosed on Day 7

Day 7 - for concurrent diagnosis of ICU-AW (elastography and MRC assessed independently, blinded to each other)

ICU-Acquired Weakness (ICU-AW) is defined as a Medical Research Council (MRC) sum score of less than 48 points.
Day 1 and Day 7 after ICU admission
Diagnostic Accuracy of Nerve SWE on Day 4 for Predicting ICU-AW on Day 7
大体时间：Day 4 and Day 7 after ICU admission

Area Under the Receiver Operating Characteristic Curve (AUC) for the mean elasticity value (measured in kilopascals, kPa) of the median and tibial nerves, assessed separately at three time points after ICU admission:

Day 4 - to predict ICU-AW diagnosed on Day 7

Day 7 - for concurrent diagnosis of ICU-AW (elastography and MRC assessed independently, blinded to each other)

ICU-Acquired Weakness (ICU-AW) is defined as a Medical Research Council (MRC) sum score of less than 48 points.
Day 4 and Day 7 after ICU admission
Diagnostic Accuracy of Nerve SWE on Day 7 for Diagnosing ICU-AW on Day 7
大体时间：Day 7 after ICU admission

Area Under the Receiver Operating Characteristic Curve (AUC) for the mean elasticity value (measured in kilopascals, kPa) of the median and tibial nerves, assessed separately at three time points after ICU admission:

Day 7 - for concurrent diagnosis of ICU-AW (elastography and MRC assessed independently, blinded to each other)

ICU-Acquired Weakness (ICU-AW) is defined as a Medical Research Council (MRC) sum score of less than 48 points.
Day 7 after ICU admission

次要结果测量

结果测量
措施说明
大体时间
Change in Nerve Elasticity
大体时间：Day 1 to Day 7 after ICU admission
Absolute and relative change in the shear wave elastography (SWE) value (in kPa) of the median and tibial nerves from baseline (Day 1) to Day 7.
Day 1 to Day 7 after ICU admission
Correlation between Nerve Elasticity and Disease Severity
大体时间：Day 7
Spearman's correlation coefficient will be calculated to assess the relationship between the baseline (Day 7) nerve SWE values and the baseline Sequential Organ Failure Assessment (SOFA) score.
Day 7

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

First Affiliated Hospital of Wannan Medical College

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2027年6月30日

研究完成 (估计的)

2027年6月30日

研究注册日期

首次提交

2026年5月11日

首先提交符合 QC 标准的

2026年5月14日

首次发布 (实际的)

2026年5月18日

研究记录更新

最后更新发布 (实际的)

2026年6月16日

上次提交的符合 QC 标准的更新

2026年6月13日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026-ICU01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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