Muscle Evaluation of Patients Infected by the Coronavirus

SARS-CoV-2 Acute Respiratory Disease Clinical Trial

Official title:

Muscle Evaluation of Patients Infected by the Coronavirus Requiring Mechanical Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05063214
• Other study ID #: 49075421.0.0000.0071
• Secondary ID: 4.923.576
• Status: Recruiting
• Start date: September 30, 2021
• Est. completion date: September 2022

Study information

• Verified date: October 2021
• Source: Hospital Israelita Albert Einstein
• Contact: Ricardo K Nawa, PT MSc PhD
• Phone: +55 11 2151-0603
• Email: ricardo.nawa[@]einstein.br
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) presents risk to develop muscle weakness associated with prolonged period of mechanical ventilation support and hospital stay.

Description:

Intensive care unit (ICU) acquired muscle weakness affects both respiratory and peripheral muscles and can contribute to worsen clinical and functional outcomes. In this way, ultrasonography muscle evaluation could help to identify early alterations guiding the therapeutic planning and allowing to monitor the interventions performed. Therefore, the investigators intend to follow up mechanically ventilated patients with confirmed diagnosis of COVID-19 during ICU stay to quantify the diaphragm, parasternal intercostal, abdominals and femoral quadriceps muscles thickness assessed by ultrasonography. Additionally, functional capacity, frailty and level of physical activity will be evaluated and followed for pre-admission condition and 30, 90 and 180 days after hospital discharge .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients admitted to ICU
• having a confirmed diagnosis of COVID-19
• requiring invasive mechanical ventilation.

Exclusion Criteria:

• exclusive palliative care;
• 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.

Related Conditions & MeSH terms

• Coronavirus Infections
• Respiration Disorders
• Respiratory Tract Diseases
• SARS-CoV-2 Acute Respiratory Disease

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

References & Publications (20)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Intensive Care Med. 2015 Apr;41(4):734. Sebastien-Bolz, Steffen [corrected to Bolz, Steffen-Sebastien]. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. 2021 Mar 27. doi: 10.1002/jum.15706. [Epub ahead of print] Review. — View Citation

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. Erratum in: JAMA. 2014 Feb 12;311(6):625. Padhke, Rahul [corrected to Phadke, Rahul]. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle thickness	Change in the thickness of the diaphragm and quadriceps femoris muscles.	Day 1, 5, and within 24 hours after ICU discharge.
Secondary	Respiratory muscle thickness	Change in the thickness of the intercostal and abdominal wall muscles.	At the end of data collection, within 24 hours after ICU discharge.
Secondary	Muscle thickness and functional outcomes	Verify the correlation between quadriceps femoris muscle thickness change and echogenicity with functional outcomes (Barthe Index, International Physical Activities Questionnaire, and the Clinical Frailty Score).	At the end of data collection, within 24 hours after ICU discharge.
Secondary	Grip strength and clinical outcomes	Verify the correlation between grip strength (measured by the Dynamometer Grip Strength) and clinical outcomes (Barthe Index, International Physical Activities Questionnaire, and the Clinical Frailty Score).	At the end of data collection, within 24 hours after ICU discharge.
Secondary	Mobility level correlation with clinical and functional outcomes	Verify the correlation between mobility level (measured by the Perme Intensive Care Unit Mobility Score) with clinical and functional outcomes (Barthe Index, International Physical Activities Questionnaire, and the Clinical Frailty Score).	At the end of data collection, within 24 hours after ICU discharge.