Muscle Evaluation of Patients Infected by the Coronavirus

Study Overview
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Brief Summary
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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.

Detailed Description
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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 .

Official Title
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Muscle Evaluation of Patients Infected by the Coronavirus Requiring Mechanical Ventilation

Conditions
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SARS-CoV-2 Acute Respiratory Disease

Intervention / Treatment
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* Diagnostic Test: Muscle ultrasound evaluation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ultrasound assessment<br>Muscle ultrasound evaluation | Diagnostic Test: Muscle ultrasound evaluation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle thickness | Change in the thickness of the diaphragm and quadriceps femoris muscles. | Day 1, 5, and within 24 hours after ICU discharge. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronavirus, SARS-CoV-2, COVID-19, Intensive Care Units, Ultrasonography