Muscle Evaluation of Patients Infected by the Coronavirus

• Conditions: SARS-CoV-2 Acute Respiratory Disease
• Interventions: Diagnostic Test: Muscle ultrasound evaluation

• Registration Number: NCT05063214
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief 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.

Detailed 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 .

Study Timeline

• Study First Submitted: 2021-09-04
• Study First Submitted QC: 2021-09-20
• Study Start: 2021-09-30
• Status Verified: 2021-10
• Study First Posted: 2021-10-01
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-06
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ultrasound assessment	Muscle ultrasound evaluation	Muscle ultrasound evaluation

Primary Outcome Measures

Name	Time	Method
Muscle thickness	Day 1, 5, and within 24 hours after ICU discharge.	Change in the thickness of the diaphragm and quadriceps femoris muscles.

Secondary Outcome Measures

Name	Time	Method
Respiratory muscle thickness	At the end of data collection, within 24 hours after ICU discharge.	Change in the thickness of the intercostal and abdominal wall muscles.
Muscle thickness and functional outcomes	At the end of data collection, within 24 hours after ICU discharge.	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).
Grip strength and clinical outcomes	At the end of data collection, within 24 hours after ICU discharge.	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).
Mobility level correlation with clinical and functional outcomes	At the end of data collection, within 24 hours after ICU discharge.	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).

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein; 🇧🇷 São Paulo, Brazil