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NCT Number: NCT07032870

Physical Therapist Inter-Rater Reliability in Neuro-Muscle Ultrasound in Critically Ill Patients

The goal of this observational study is to evaluate the feasibility and inter-rater reliability of muscle and peripheral nerve ultrasound for the early detection of ICU-acquired weakness (ICU-AW) in critically ill patients.

The main questions it aims to answer are:

Can ICU physical therapists consistently measure muscle and nerve ultrasound variables such as muscle thickness, cross-sectional area, pennation angle, and echogenicity in critically ill patients?

Do clinical scales (MRC-SS and FSS-ICU) show inter-evaluator agreement and correlate with ultrasound findings?

Participants are adult ICU patients at Clínica INDISA who are undergoing routine neuromuscular assessments by trained physical therapists. Each patient will be evaluated by three independent raters using ultrasound and standardized clinical scales. Data will be collected and analyzed to determine inter-rater reliability and correlations between clinical and imaging findings.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clínica INDISA

Santiago, Metropolitan Region, 7500912, Chile

Location status: Recruiting

Location contact

Benito J Arévalo, MSc.

SUB_INVESTIGATOR

Felipe A Castillo, MSc.

CONTACT

[email protected]

+56992246802

Nicole A Peña, PT

SUB_INVESTIGATOR

Óscar L Arellano, MSc. PhD Candidate

CONTACT

[email protected]

+56961479414

About this study

This observational, cross-sectional pilot study aims to assess the inter-rater reliability of muscle and peripheral nerve ultrasound and functional clinical scales in the diagnosis of ICU-acquired weakness (ICU-AW). The study involves adult patients admitted to the Adult Critical Care Unit at Clínica INDISA (Santiago, Chile). Participants will undergo muscle ultrasound of the quadriceps (measuring anterior compartment thickness, cross-sectional area, and pennation angle) and peripheral nerve ultrasound (assessing cross-sectional area and echogenicity of specific nerves) performed by three trained physical therapists. Clinical assessments using the MRC Sum Score (MRC-SS) and the Functional Status Score for the ICU (FSS-ICU) will also be performed by each rater.

The main aim is to evaluate the agreement between raters using the intraclass correlation coefficient (ICC) for ultrasound variables and Kendall's W for functional scales. The study will also explore correlations between clinical scores and ultrasound findings using Pearson or Spearman correlation coefficients. Echogenicity will be quantified using ImageJ software.

All procedures are performed at bedside using portable ultrasound equipment, and evaluations follow safety guidelines for critically ill patients. The results of this study will contribute to validating physical therapists as reliable operators for early identification of ICU-AW using ultrasound-based tools and standardized clinical assessments.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥18 years old) admitted to the Adult Intensive Care Unit (ICU) of Clínica INDISA.
  • Conscious and clinically stable at the time of assessment.
  • Able to provide written informed consent.

Exclusion criteria

  • Known allergy to ultrasound gel.
  • Body mass index (BMI) ≥ 30 kg/m².
  • Pre-existing neuromuscular disease.
  • Continuous renal replacement therapy or severe hepatic coagulopathy.
  • Platelet count < 20,000/µL.
  • Lower limb amputation or recent fractures.
  • Ongoing chemotherapy or immunosuppressive treatment with corticosteroids.
  • Epileptic status or pregnancy.

Treatment and study plan

Primary outcomes

  1. Inter-rater reliability of quadriceps muscle ultrasound measurements

    Time frame: Assessed once within 60 days following ICU admission

    Intraclass correlation coefficient (ICC) between three evaluators for ultrasound variables including quadriceps muscle thickness, rectus femoris and vastus intermedius cross-sectional area, and pennation angle.

  2. Peripheral Nerve Ultrasound Inter-Rater Reliability

    Time frame: Assessed once within 60 days following ICU admission

    Intraclass correlation coefficient (ICC) between three evaluators for cross-sectional area and echogenicity of peripheral nerves (median, ulnar, tibial, and fibular) measured by ultrasound.

Secondary outcomes

  1. Inter-rater agreement of Functional Status Score for the ICU (FSS-ICU)

    Time frame: Assessed once within 60 days following ICU admission

    Kendall's W coefficient to assess the level of agreement among three physical therapists applying the FSS-ICU scale in critically ill patients.

  2. Inter-Rater Agreement of MRC Sum Score

    Time frame: Assessed once within 60 days following ICU admission

    Kendall's W coefficient to determine the agreement between three physical therapists applying the MRC-SS to assess muscle strength in ICU patients.

  3. Correlation between clinical scales and ultrasound findings

    Time frame: Assessed once within 60 days following ICU admission

    Pearson or Spearman correlation coefficients between MRC-SS/FSS-ICU results and quantitative ultrasound parameters.

Study contacts

Contact information is provided by the study sponsor or research team.

Benito J Arévalo, MSc.

CONTACT

[email protected]

+56962198575

Óscar L Arellano, MSc. PhD Candidate

CONTACT

[email protected]

+56961479414

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Collaborators

  • Clinica Indisa

Registry information

Official study title

Pilot Study: Validation of Operators and Inter-Evaluator Variability in Diagnostic Strategies for ICU-Acquired Weakness (NMusICU-R)

Acronym: NMusICU-R

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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