Evaluation of Peripheral Muscle With Ultrassonografic of Critical Patients With Covid-19

NCT05055440 | Completed DMC

• 1 other identifier: UFPE
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, the tools available for assessing peripheral muscle dysfunction in the intensive care setting require patient collaboration. Several studies have shown that peripheral muscle ultrasound is capable of reliably detecting morphological changes in critically ill patients, in addition to contributing to the identification of patients at higher risk of prolonged complications, especially when performed daily. In this sense, a valid, non-volitional alternative capable of determining muscle mass is through ultrasound assessment. However, current studies are characterized by a lack of standardization in their protocols, which include proper positioning of limbs, transducer, clear reference points and techniques for better visualization of the assessed muscle, in addition to significant methodological defects and inadequate sample sizes. We believe that, together with a tool capable of determining muscle mass and being a safe and non-invasive method, we can contribute to a more complete assessment of these patients, exploring outcomes such as survival, length of stay in the ICU, extubation success and functional capacity. In addition to having the potential to serve as a biomarker of muscle strength during rehabilitation, given little knowledge about the long-term physical consequences of COVID-19, thus promoting a more complete assessment, exploring morphological characteristics of the peripheral muscles resulting from the hospitalization process. and assisting the physiotherapist in clinical decision making in rehabilitation.

Conditions

COVID-19 Respiratory Infection

Keywords

SARS-CoV-2; Intensive care unit; Coronavirus; Peripheral muscle; Atrophy muscular; Uultrasound evaluation; Critically ill

Outcome Measures

Primary Outcomes (2)

• Peripheral muscle thickess measured during ultrasonography

  Peripheral muscle thickess expressed in centimeters

  25 minutes

• Cross-sectional area measured during ultrasonography

  Cross-sectional area thickening expressed in square centimeters

  10 minutes

Secondary Outcomes (5)

• Murray Score (LIS)

  1 hours

• Duration of mechanical ventilation (MV days)

  Through study completion, an average of 1 week

• ICU Mortality

  Through study completion, an average of 1 week

• Simplified Acute Physiological Score (SAPS3)

  10 minutes

• Acute Physiologic and Chronic Health Evaluation II - APACHE II

  10 minutes

Study Arms (1)

Mechanically ventilated patients with COVID-19 in the ICU

Mechanically ventilated patients with COVID-19 admitted to the intensive care unit using sedation and neuromuscular blocker

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The sample consisted of volunteers with COVID - 19 admitted to the SRAG ICU on mechanical ventilation due to acute respiratory failure.

You may qualify if:

• Individuals of both genders;
• Age group over 18 years old;
• Individuals who had a confirmed diagnosis for COVID-19 considering their positivity through the RT-PCR exam on mechanical ventilation due to acute respiratory failure

You may not qualify if:

• \- Patients with neurological impairment or known myopathies

Sponsors & Collaborators

• University of Pernambuco: lead
• Universidade Federal de Pernambuco: collaborator

Study Sites (1)

Physical Therapy Department, Universidade Federal de Pernambuco

Recife, Pernambuco, 50670-901, Brazil

Location

Related Publications (16)

• Dall' Acqua AM, Sachetti A, Santos LJ, Lemos FA, Bianchi T, Naue WS, Dias AS, Sbruzzi G, Vieira SR; MoVe- ICU Group. Use of neuromuscular electrical stimulation to preserve the thickness of abdominal and chest muscles of critically ill patients: A randomized clinical trial. J Rehabil Med. 2017 Jan 19;49(1):40-48. doi: 10.2340/16501977-2168.

  PMID: 28101565 RESULT

• Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.

  PMID: 18511703 RESULT

• Annetta MG, Pittiruti M, Silvestri D, Grieco DL, Maccaglia A, La Torre MF, Magarelli N, Mercurio G, Caricato A, Antonelli M. Ultrasound assessment of rectus femoris and anterior tibialis muscles in young trauma patients. Ann Intensive Care. 2017 Oct 6;7(1):104. doi: 10.1186/s13613-017-0326-x.

  PMID: 28986861 RESULT

• 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 RESULT

• 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 RESULT

• Gruther W, Benesch T, Zorn C, Paternostro-Sluga T, Quittan M, Fialka-Moser V, Spiss C, Kainberger F, Crevenna R. Muscle wasting in intensive care patients: ultrasound observation of the M. quadriceps femoris muscle layer. J Rehabil Med. 2008 Mar;40(3):185-9. doi: 10.2340/16501977-0139.

  PMID: 18292919 RESULT

• Hammond K, Mampilly J, Laghi FA, Goyal A, Collins EG, McBurney C, Jubran A, Tobin MJ. Validity and reliability of rectus femoris ultrasound measurements: Comparison of curved-array and linear-array transducers. J Rehabil Res Dev. 2014;51(7):1155-64. doi: 10.1682/JRRD.2013.08.0187.

  PMID: 25437305 RESULT

• Joskova V, Patkova A, Havel E, Najpaverova S, Uramova D, Kovarik M, Zadak Z, Hronek M. Critical evaluation of muscle mass loss as a prognostic marker of morbidity in critically ill patients and methods for its determination. J Rehabil Med. 2018 Aug 22;50(8):696-704. doi: 10.2340/16501977-2368.

  PMID: 30080234 RESULT

• Mourtzakis M, Parry S, Connolly B, Puthucheary Z. Skeletal Muscle Ultrasound in Critical Care: A Tool in Need of Translation. Ann Am Thorac Soc. 2017 Oct;14(10):1495-1503. doi: 10.1513/AnnalsATS.201612-967PS.

  PMID: 28820608 RESULT

• Palakshappa JA, Reilly JP, Schweickert WD, Anderson BJ, Khoury V, Shashaty MG, Fitzgerald D, Forker C, Butler K, Ittner CA, Feng R, Files DC, Bonk MP, Christie JD, Meyer NJ. Quantitative peripheral muscle ultrasound in sepsis: Muscle area superior to thickness. J Crit Care. 2018 Oct;47:324-330. doi: 10.1016/j.jcrc.2018.04.003.

  PMID: 30224027 RESULT

• Parry SM, El-Ansary D, Cartwright MS, Sarwal A, Berney S, Koopman R, Annoni R, Puthucheary Z, Gordon IR, Morris PE, Denehy L. Ultrasonography in the intensive care setting can be used to detect changes in the quality and quantity of muscle and is related to muscle strength and function. J Crit Care. 2015 Oct;30(5):1151.e9-14. doi: 10.1016/j.jcrc.2015.05.024. Epub 2015 Jun 3.

  PMID: 26211979 RESULT

• Parry SM, Puthucheary ZA. The impact of extended bed rest on the musculoskeletal system in the critical care environment. Extrem Physiol Med. 2015 Oct 9;4:16. doi: 10.1186/s13728-015-0036-7. eCollection 2015.

  PMID: 26457181 RESULT

• Sarwal A, Parry SM, Berry MJ, Hsu FC, Lewis MT, Justus NW, Morris PE, Denehy L, Berney S, Dhar S, Cartwright MS. Interobserver Reliability of Quantitative Muscle Sonographic Analysis in the Critically Ill Population. J Ultrasound Med. 2015 Jul;34(7):1191-200. doi: 10.7863/ultra.34.7.1191.

  PMID: 26112621 RESULT

• Tillquist M, Kutsogiannis DJ, Wischmeyer PE, Kummerlen C, Leung R, Stollery D, Karvellas CJ, Preiser JC, Bird N, Kozar R, Heyland DK. Bedside ultrasound is a practical and reliable measurement tool for assessing quadriceps muscle layer thickness. JPEN J Parenter Enteral Nutr. 2014 Sep;38(7):886-90. doi: 10.1177/0148607113501327. Epub 2013 Aug 26.

  PMID: 23980134 RESULT

• Turton P, Hay R, Taylor J, McPhee J, Welters I. Human limb skeletal muscle wasting and architectural remodeling during five to ten days intubation and ventilation in critical care - an observational study using ultrasound. BMC Anesthesiol. 2016 Nov 29;16(1):119. doi: 10.1186/s12871-016-0269-z.

  PMID: 27894277 RESULT

• Valls-Matarin J, del Cotillo-Fuente M, Grane-Mascarell N, Quintana S. [Variation of muscle mass and weight in critical patient]. Enferm Intensiva. 2015 Jul-Sep;26(3):86-91. doi: 10.1016/j.enfi.2015.05.001. Epub 2015 Jul 9. Spanish.

  PMID: 26165624 RESULT

MeSH Terms

Conditions

Coronavirus Infections; Muscular Atrophy; Critical Illness

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Pedro Henrique de Moura

  Universidade Federal de Pernambuco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 24, 2021
• Study Start: December 20, 2021
• Primary Completion: May 20, 2022
• Study Completion: June 30, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)