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

NCT07594249 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital of Wannan Medical College

Phase

Observational

Started

2026-07-01

Last updated

2026-06-16

Condition(s) studied

ICU-acquired WeaknessCritical Illness PolyneuropathyCritical Illness Myopathy

Investigational drug(s) / intervention(s)

Nerve Ultrasound with Shear Wave Elastography

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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

85 Years

Healthy volunteers

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.

Primary outcome measure(s)

Diagnostic Accuracy of Nerve SWE on Day 1 for Predicting ICU-AW on Day 7 — 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.
Diagnostic Accuracy of Nerve SWE on Day 4 for Predicting ICU-AW on Day 7 — 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.
Diagnostic Accuracy of Nerve SWE on Day 7 for Diagnosing ICU-AW on Day 7 — 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.

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)	Wuhu	Anhui

More First Affiliated Hospital of Wannan Medical College trials in China

EIT Evaluation of Different Antihypertensive Agents on the Ventilation-Perfusion Ratio in Patients With Acute Respiratory Failure Starting soon

Inferior Vena Cava Collapsibility Index and Intradialytic Hypotension Recruiting

The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis Recruiting

Effects of Esmolol on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock Starting soon

Rare Disease Registry Database for Movement Disorders in Southern Anhui Province Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07594249 on ClinicalTrials.gov ↗ ← All trials in China