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

NCT ID: NCT07032870

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-08
• Study Completion Date: 2025-12-09

Brief Summary

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.

Detailed Description

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.

Conditions

Critical Illness

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Critically Ill Patients

Adult ICU patients at Clínica INDISA evaluated by three physical therapists using bedside ultrasound of the quadriceps muscle and peripheral nerves, and assessed with clinical scales (MRC-SS and FSS-ICU) to measure inter-rater reliability and correlation of results.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinica Indisa

OTHER

Sponsor Role: collaborator

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Oscar Arellano

PhD. Candidate in Biomedical Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paola A Llanos, PhD

Role: STUDY_CHAIR

University of Chile

Locations

Clínica INDISA

Santiago, Metropolitan Region, Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Óscar L Arellano, MSc. PhD Candidate

Role: CONTACT

oscar.arellano@ug.uchile.cl

+56961479414

Benito J Arévalo, MSc.

Role: CONTACT

B.Arevalopereda@gmail.com

+56962198575

Facility Contacts

Felipe A Castillo, MSc.

Role: primary

felipe.castillo@indisa.cl

+56992246802

Óscar L Arellano, MSc. PhD Candidate

Role: backup

oscar.arellano@ug.uchile.cl

+56961479414

References

Lefaucheur JP, Nordine T, Rodriguez P, Brochard L. Origin of ICU acquired paresis determined by direct muscle stimulation. J Neurol Neurosurg Psychiatry. 2006 Apr;77(4):500-6. doi: 10.1136/jnnp.2005.070813. Epub 2005 Nov 23.

Reference Type: BACKGROUND

PMID: 16306155 (View on PubMed)

Formenti P, Umbrello M, Coppola S, Froio S, Chiumello D. Clinical review: peripheral muscular ultrasound in the ICU. Ann Intensive Care. 2019 May 17;9(1):57. doi: 10.1186/s13613-019-0531-x.

Reference Type: BACKGROUND

PMID: 31101987 (View on PubMed)

Paolo F, Valentina G, Silvia C, Tommaso P, Elena C, Martin D, Marini John J, Davide C. The possible predictive value of muscle ultrasound in the diagnosis of ICUAW in long-term critically ill patients. J Crit Care. 2022 Oct;71:154104. doi: 10.1016/j.jcrc.2022.154104. Epub 2022 Jul 4.

Reference Type: BACKGROUND

PMID: 35797827 (View on PubMed)

Lad H, Saumur TM, Herridge MS, Dos Santos CC, Mathur S, Batt J, Gilbert PM. Intensive Care Unit-Acquired Weakness: Not just Another Muscle Atrophying Condition. Int J Mol Sci. 2020 Oct 22;21(21):7840. doi: 10.3390/ijms21217840.

Reference Type: BACKGROUND

PMID: 33105809 (View on PubMed)

Elkalawy H, Sekhar P, Abosena W. Early detection and assessment of intensive care unit-acquired weakness: a comprehensive review. Acute Crit Care. 2023 Nov;38(4):409-424. doi: 10.4266/acc.2023.00703. Epub 2023 Nov 30.

Reference Type: BACKGROUND

PMID: 38052508 (View on PubMed)

Rajagopal K, Vijayan D, Thomas SM. Association of SOFA Score with Severity of Muscle Wasting in Critically Ill Patients: A Prospective Observational Study. Indian J Crit Care Med. 2023 Oct;27(10):743-747. doi: 10.5005/jp-journals-10071-24540.

Reference Type: BACKGROUND

PMID: 37908434 (View on PubMed)

Beekman R, Visser LH. High-resolution sonography of the peripheral nervous system -- a review of the literature. Eur J Neurol. 2004 May;11(5):305-14. doi: 10.1111/j.1468-1331.2004.00773.x.

Reference Type: BACKGROUND

PMID: 15142223 (View on PubMed)

Gruber L, Loizides A, Gruber H, Skalla E, Haushammer S, Horlings C, Beer R, Helbok R, Loscher WN. Differentiation of Critical Illness Myopathy and Critical Illness Neuropathy Using Nerve Ultrasonography. J Clin Neurophysiol. 2023 Nov 1;40(7):600-607. doi: 10.1097/WNP.0000000000000922. Epub 2022 Jan 25.

Reference Type: BACKGROUND

PMID: 35089907 (View on PubMed)

Grimm A, Decard BF, Axer H, Fuhr P. The Ultrasound pattern sum score - UPSS. A new method to differentiate acute and subacute neuropathies using ultrasound of the peripheral nerves. Clin Neurophysiol. 2015 Nov;126(11):2216-25. doi: 10.1016/j.clinph.2015.01.011. Epub 2015 Feb 3.

Reference Type: BACKGROUND

PMID: 25691156 (View on PubMed)

Hadda V, Khilnani GC, Kumar R, Dhunguna A, Mittal S, Khan MA, Madan K, Mohan A, Guleria R. Intra- and Inter-observer Reliability of Quadriceps Muscle Thickness Measured with Bedside Ultrasonography by Critical Care Physicians. Indian J Crit Care Med. 2017 Jul;21(7):448-452. doi: 10.4103/ijccm.IJCCM_426_16.

Reference Type: BACKGROUND

PMID: 28808365 (View on PubMed)

Di Matteo A, Moscioni E, Lommano MG, Cipolletta E, Smerilli G, Farah S, Airoldi C, Aydin SZ, Becciolini A, Bonfiglioli K, Carotti M, Carrara G, Cazenave T, Corradini D, Cosatti MA, de Agustin JJ, Destro Castaniti GM, Di Carlo M, Di Donato E, Di Geso L, Elliott A, Fodor D, Francioso F, Gabba A, Hernandez-Diaz C, Horvath R, Hurnakova J, Jesus D, Marin J, Martire MV, Mashadi Mirza R, Massarotti M, Musca AA, Nair J, Okano T, Papalopoulos I, Rosa J, Rosemffet M, Rovisco J, Rozza D, Salaffi F, Scioscia C, Scire CA, Tamas MM, Tanimura S, Ventura-Rios L, Villota-Eraso C, Villota O, Voulgari PV, Vreju FA, Vukatana G, Hereter JZ, Zanetti A, Grassi W, Filippucci E. Reliability assessment of ultrasound muscle echogenicity in patients with rheumatic diseases: Results of a multicenter international web-based study. Front Med (Lausanne). 2023 Jan 17;9:1090468. doi: 10.3389/fmed.2022.1090468. eCollection 2022.

Reference Type: BACKGROUND

PMID: 36733934 (View on PubMed)

Pardo E, El Behi H, Boizeau P, Verdonk F, Alberti C, Lescot T. Reliability of ultrasound measurements of quadriceps muscle thickness in critically ill patients. BMC Anesthesiol. 2018 Dec 27;18(1):205. doi: 10.1186/s12871-018-0647-9.

Reference Type: BACKGROUND

PMID: 30591032 (View on PubMed)

Karapinar M, Atilla Ayyildiz V, Unal M, Firat T. Ultrasound imaging of quadriceps muscle in patients with knee osteoarthritis: The test-retest and inter-rater reliability and concurrent validity of echo intensity measurement. Musculoskelet Sci Pract. 2021 Dec;56:102453. doi: 10.1016/j.msksp.2021.102453. Epub 2021 Sep 1.

Reference Type: BACKGROUND

PMID: 34507044 (View on PubMed)

Turan Z, Topaloglu M, Ozyemisci Taskiran O. Medical Research Council-sumscore: a tool for evaluating muscle weakness in patients with post-intensive care syndrome. Crit Care. 2020 Sep 18;24(1):562. doi: 10.1186/s13054-020-03282-x. No abstract available.

Reference Type: BACKGROUND

PMID: 32948221 (View on PubMed)

Derde S, Hermans G, Derese I, Guiza F, Hedstrom Y, Wouters PJ, Bruyninckx F, D'Hoore A, Larsson L, Van den Berghe G, Vanhorebeek I. Muscle atrophy and preferential loss of myosin in prolonged critically ill patients. Crit Care Med. 2012 Jan;40(1):79-89. doi: 10.1097/CCM.0b013e31822d7c18.

Reference Type: BACKGROUND

PMID: 21926599 (View on PubMed)

Wilcox SR. Corticosteroids and neuromuscular blockers in development of critical illness neuromuscular abnormalities: A historical review. J Crit Care. 2017 Feb;37:149-155. doi: 10.1016/j.jcrc.2016.09.018. Epub 2016 Sep 26.

Reference Type: BACKGROUND

PMID: 27736708 (View on PubMed)

Stevens RD, Marshall SA, Cornblath DR, Hoke A, Needham DM, de Jonghe B, Ali NA, Sharshar T. A framework for diagnosing and classifying intensive care unit-acquired weakness. Crit Care Med. 2009 Oct;37(10 Suppl):S299-308. doi: 10.1097/CCM.0b013e3181b6ef67.

Reference Type: BACKGROUND

PMID: 20046114 (View on PubMed)

Fan E, Cheek F, Chlan L, Gosselink R, Hart N, Herridge MS, Hopkins RO, Hough CL, Kress JP, Latronico N, Moss M, Needham DM, Rich MM, Stevens RD, Wilson KC, Winkelman C, Zochodne DW, Ali NA; ATS Committee on ICU-acquired Weakness in Adults; American Thoracic Society. An official American Thoracic Society Clinical Practice guideline: the diagnosis of intensive care unit-acquired weakness in adults. Am J Respir Crit Care Med. 2014 Dec 15;190(12):1437-46. doi: 10.1164/rccm.201411-2011ST.

Reference Type: BACKGROUND

PMID: 25496103 (View on PubMed)

Barreiro E. Models of disuse muscle atrophy: therapeutic implications in critically ill patients. Ann Transl Med. 2018 Jan;6(2):29. doi: 10.21037/atm.2017.12.12.

Reference Type: BACKGROUND

PMID: 29430446 (View on PubMed)

Wang W, Xu C, Ma X, Zhang X, Xie P. Intensive Care Unit-Acquired Weakness: A Review of Recent Progress With a Look Toward the Future. Front Med (Lausanne). 2020 Nov 23;7:559789. doi: 10.3389/fmed.2020.559789. eCollection 2020.

Reference Type: BACKGROUND

PMID: 33330523 (View on PubMed)

Schefold JC, Wollersheim T, Grunow JJ, Luedi MM, Z'Graggen WJ, Weber-Carstens S. Muscular weakness and muscle wasting in the critically ill. J Cachexia Sarcopenia Muscle. 2020 Dec;11(6):1399-1412. doi: 10.1002/jcsm.12620. Epub 2020 Sep 7.

Reference Type: BACKGROUND

PMID: 32893974 (View on PubMed)

Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. No abstract available.

Reference Type: BACKGROUND

PMID: 24758618 (View on PubMed)

Vanhorebeek I, Latronico N, Van den Berghe G. ICU-acquired weakness. Intensive Care Med. 2020 Apr;46(4):637-653. doi: 10.1007/s00134-020-05944-4. Epub 2020 Feb 19.

Reference Type: BACKGROUND

PMID: 32076765 (View on PubMed)

De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.

Reference Type: BACKGROUND

PMID: 12472328 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

176-25-24

Identifier Type: -

Identifier Source: org_study_id