Muscle Evaluation of Patients Infected by the Coronavirus
NCT ID: NCT05063214
Last Updated: 2021-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
138 participants
OBSERVATIONAL
2021-09-30
2022-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ultrasound assessment
Muscle ultrasound evaluation
Muscle ultrasound evaluation
Muscle ultrasound evaluation will be performed in patients admitted with COVID-19 requiring invasive mechanical ventilation. The measurements of thickness and thickening fraction will occur for diaphragm, abdominal - rectus abdominis, internal oblique, external oblique and transverse abdomen - and parasternal intercostal muscles. Serial measurements of the thickness and echogenicity of the quadriceps femoris muscle will also be performed.
Interventions
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Muscle ultrasound evaluation
Muscle ultrasound evaluation will be performed in patients admitted with COVID-19 requiring invasive mechanical ventilation. The measurements of thickness and thickening fraction will occur for diaphragm, abdominal - rectus abdominis, internal oblique, external oblique and transverse abdomen - and parasternal intercostal muscles. Serial measurements of the thickness and echogenicity of the quadriceps femoris muscle will also be performed.
Eligibility Criteria
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Inclusion Criteria
* having a confirmed diagnosis of COVID-19
* requiring invasive mechanical ventilation.
Exclusion Criteria
* neuromuscular diseases;
* patients who evolve with the need for lower limb amputation;
* previous known diaphragm malformations and dysfunctions;
* patients transferred from other institutions under invasive mechanical ventilation;
* clinical conditions that make the respiratory and peripheral muscle assessment through ultrasound unfeasible.
18 Years
ALL
No
Sponsors
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Hospital Israelita Albert Einstein
OTHER
Responsible Party
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Principal Investigators
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Caroline G Mól, PT
Role: STUDY_CHAIR
Hospital Israelita Albert Einstein
Locations
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Hospital Israelita Albert Einstein
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Conway H, Lau G, Zochios V. Personalizing Invasive Mechanical Ventilation Strategies in Coronavirus Disease 2019 (COVID-19)-Associated Lung Injury: The Utility of Lung Ultrasound. J Cardiothorac Vasc Anesth. 2020 Oct;34(10):2571-2574. doi: 10.1053/j.jvca.2020.04.062. Epub 2020 May 15. No abstract available.
Patel Z, Franz CK, Bharat A, Walter JM, Wolfe LF, Koralnik IJ, Deshmukh S. Diaphragm and Phrenic Nerve Ultrasound in COVID-19 Patients and Beyond: Imaging Technique, Findings, and Clinical Applications. J Ultrasound Med. 2022 Feb;41(2):285-299. doi: 10.1002/jum.15706. Epub 2021 Mar 27.
Shi Z, de Vries HJ, Vlaar APJ, van der Hoeven J, Boon RA, Heunks LMA, Ottenheijm CAC; Dutch COVID-19 Diaphragm Investigators. Diaphragm Pathology in Critically Ill Patients With COVID-19 and Postmortem Findings From 3 Medical Centers. JAMA Intern Med. 2021 Jan 1;181(1):122-124. doi: 10.1001/jamainternmed.2020.6278.
Vivier E, Mekontso Dessap A, Dimassi S, Vargas F, Lyazidi A, Thille AW, Brochard L. Diaphragm ultrasonography to estimate the work of breathing during non-invasive ventilation. Intensive Care Med. 2012 May;38(5):796-803. doi: 10.1007/s00134-012-2547-7. Epub 2012 Apr 5.
Goligher EC, Fan E, Herridge MS, Murray A, Vorona S, Brace D, Rittayamai N, Lanys A, Tomlinson G, Singh JM, Bolz SS, Rubenfeld GD, Kavanagh BP, Brochard LJ, Ferguson ND. Evolution of Diaphragm Thickness during Mechanical Ventilation. Impact of Inspiratory Effort. Am J Respir Crit Care Med. 2015 Nov 1;192(9):1080-8. doi: 10.1164/rccm.201503-0620OC.
Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.
Sklar MC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Rittayamai N, Harhay MO, Reid WD, Tomlinson G, Rozenberg D, McClelland W, Riegler S, Slutsky AS, Brochard L, Ferguson ND, Goligher EC. Association of Low Baseline Diaphragm Muscle Mass With Prolonged Mechanical Ventilation and Mortality Among Critically Ill Adults. JAMA Netw Open. 2020 Feb 5;3(2):e1921520. doi: 10.1001/jamanetworkopen.2019.21520.
Itagaki T, Nakanishi N, Takashima T, Ueno Y, Tane N, Tsunano Y, Nunomura T, Oto J. Effect of controlled ventilation during assist-control ventilation on diaphragm thickness : a post hoc analysis of an observational study. J Med Invest. 2020;67(3.4):332-337. doi: 10.2152/jmi.67.332.
Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC.
Goligher EC, Laghi F, Detsky ME, Farias P, Murray A, Brace D, Brochard LJ, Bolz SS, Rubenfeld GD, Kavanagh BP, Ferguson ND. Measuring diaphragm thickness with ultrasound in mechanically ventilated patients: feasibility, reproducibility and validity. Intensive Care Med. 2015 Apr;41(4):642-9. doi: 10.1007/s00134-015-3687-3. Epub 2015 Feb 19.
Vivier E, Roussey A, Doroszewski F, Rosselli S, Pommier C, Carteaux G, Mekontso Dessap A. Atrophy of Diaphragm and Pectoral Muscles in Critically Ill Patients. Anesthesiology. 2019 Sep;131(3):569-579. doi: 10.1097/ALN.0000000000002737.
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.
Nakanishi N, Oto J, Ueno Y, Nakataki E, Itagaki T, Nishimura M. Change in diaphragm and intercostal muscle thickness in mechanically ventilated patients: a prospective observational ultrasonography study. J Intensive Care. 2019 Dec 2;7:56. doi: 10.1186/s40560-019-0410-4. eCollection 2019.
Zambon M, Beccaria P, Matsuno J, Gemma M, Frati E, Colombo S, Cabrini L, Landoni G, Zangrillo A. Mechanical Ventilation and Diaphragmatic Atrophy in Critically Ill Patients: An Ultrasound Study. Crit Care Med. 2016 Jul;44(7):1347-52. doi: 10.1097/CCM.0000000000001657.
Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.
Tuinman PR, Jonkman AH, Dres M, Shi ZH, Goligher EC, Goffi A, de Korte C, Demoule A, Heunks L. Respiratory muscle ultrasonography: methodology, basic and advanced principles and clinical applications in ICU and ED patients-a narrative review. Intensive Care Med. 2020 Apr;46(4):594-605. doi: 10.1007/s00134-019-05892-8. Epub 2020 Jan 14.
Formenti P, Umbrello M, Dres M, Chiumello D. Ultrasonographic assessment of parasternal intercostal muscles during mechanical ventilation. Ann Intensive Care. 2020 Sep 7;10(1):120. doi: 10.1186/s13613-020-00735-y.
Shi ZH, de Vries H, de Grooth HJ, Jonkman AH, Zhang Y, Haaksma M, van de Ven PM, de Man AAME, Girbes A, Tuinman PR, Zhou JX, Ottenheijm C, Heunks L. Changes in Respiratory Muscle Thickness during Mechanical Ventilation: Focus on Expiratory Muscles. Anesthesiology. 2021 May 1;134(5):748-759. doi: 10.1097/ALN.0000000000003736.
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.
Other Identifiers
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4.923.576
Identifier Type: OTHER
Identifier Source: secondary_id
49075421.0.0000.0071
Identifier Type: -
Identifier Source: org_study_id
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