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

14. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

98

Kontakter og lokationer

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Studiekontakt

Studiesteder

  • Kina
    • Anhui
      • Wuhu, Anhui, Kina, 241001
        • The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
        • Kontakt:

Deltagelseskriterier

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Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Diagnostisk test: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diagnostic Accuracy of Nerve SWE on Day 1 for Predicting ICU-AW on Day 7
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Nerve Elasticity
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

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Sponsor

First Affiliated Hospital of Wannan Medical College

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

30. juni 2027

Studieafslutning (Anslået)

30. juni 2027

Datoer for studieregistrering

Først indsendt

11. maj 2026

Først indsendt, der opfyldte QC-kriterier

14. maj 2026

Først opslået (Faktiske)

18. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-ICU01

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