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

NCT07594249 | Not Yet Recruiting

• 1 other identifier: 2026-ICU01
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Illness Myopathy; ICU-acquired Weakness; Critical Illness Polyneuropathy

Keywords

Shear Wave Elastography; Peripheral Nerve; Ultrasonography; Critical Care; Early Diagnosis

Outcome Measures

Primary Outcomes (3)

• Diagnostic Accuracy of Nerve SWE on Day 1 for Predicting ICU-AW on Day 7

  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

  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

  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

Secondary Outcomes (2)

• Change in Nerve Elasticity

  Day 1 to Day 7 after ICU admission

• Correlation between Nerve Elasticity and Disease Severity

  Day 7

Study Arms (1)

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.

Diagnostic Test: Nerve Ultrasound with Shear Wave Elastography

Interventions

Nerve Ultrasound with Shear Wave Elastography DIAGNOSTIC_TEST

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.

ICU Patients on Mechanical Ventilation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Wannan Medical College: lead

Study Sites (1)

The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)

Wuhu, Anhui, 241001, China

Location

MeSH Terms

Conditions

Polyneuropathies; Disease

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

qiancheng xu, PhD

CONTACT

+86-18297529106; xu19871011@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)