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

NCT07032870 | Recruiting

• 1 other identifier: 176-25-24
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

critical illness; ultrasound; Inter-rater reliability; physical therapist

Outcome Measures

Primary Outcomes (2)

• Inter-rater reliability of quadriceps muscle ultrasound measurements

  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.

  Assessed once within 60 days following ICU admission

• Peripheral Nerve Ultrasound Inter-Rater Reliability

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

  Assessed once within 60 days following ICU admission

Secondary Outcomes (3)

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

  Assessed once within 60 days following ICU admission

• Inter-Rater Agreement of MRC Sum Score

  Assessed once within 60 days following ICU admission

• Correlation between clinical scales and ultrasound findings

  Assessed once within 60 days following ICU admission

Study Arms (1)

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.

Eligibility Criteria

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

Study Population

The study population consists of adult patients admitted to the Adult Intensive Care Unit (ICU) of Clínica INDISA in Santiago, Chile. Participants will be selected during their hospitalization for critical illness and evaluated on a randomly chosen day during their ICU stay. All participants will be physically and cognitively able to provide informed consent.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chile: lead
• Clinica Indisa: collaborator

Study Sites (1)

Clínica INDISA

Santiago, Metropolitan Region, 7500912, Chile

RECRUITING

Related Publications (24)

• 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.

  PMID: 16306155 BACKGROUND

• 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.

  PMID: 31101987 BACKGROUND

• 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.

  PMID: 35797827 BACKGROUND

• 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.

  PMID: 33105809 BACKGROUND

• 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.

  PMID: 38052508 BACKGROUND

• 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.

  PMID: 37908434 BACKGROUND

• 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.

  PMID: 15142223 BACKGROUND

• 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.

  PMID: 35089907 BACKGROUND

• 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.

  PMID: 25691156 BACKGROUND

• 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.

  PMID: 28808365 BACKGROUND

• 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.

  PMID: 36733934 BACKGROUND

• 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.

  PMID: 30591032 BACKGROUND

• 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.

  PMID: 34507044 BACKGROUND

• 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.

  PMID: 32948221 BACKGROUND

• 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.

  PMID: 21926599 BACKGROUND

• 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.

  PMID: 27736708 BACKGROUND

• 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.

  PMID: 20046114 BACKGROUND

• 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.

  PMID: 25496103 BACKGROUND

• 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.

  PMID: 29430446 BACKGROUND

• 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.

  PMID: 33330523 BACKGROUND

• 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.

  PMID: 32893974 BACKGROUND

• 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.

  PMID: 24758618 BACKGROUND

• 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.

  PMID: 32076765 BACKGROUND

• 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.

  PMID: 12472328 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paola A Llanos, PhD

  University of Chile

  STUDY CHAIR

Central Study Contacts

Óscar L Arellano, MSc. PhD Candidate

CONTACT

+56961479414; oscar.arellano@ug.uchile.cl

Benito J Arévalo, MSc.

CONTACT

+56962198575; B.Arevalopereda@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD. Candidate in Biomedical Sciences

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 24, 2025
• Study Start: February 8, 2025
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)