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Clinical Trials/NCT05063214
NCT05063214
Unknown
Not Applicable

Muscle Evaluation of Patients Infected by the Coronavirus Requiring Mechanical Ventilation

Hospital Israelita Albert Einstein1 site in 1 country138 target enrollmentSeptember 30, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
SARS-CoV-2 Acute Respiratory Disease
Sponsor
Hospital Israelita Albert Einstein
Enrollment
138
Locations
1
Primary Endpoint
Muscle thickness
Last Updated
4 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
September 30, 2021
End Date
September 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Muscle thickness

Time Frame: Day 1, 5, and within 24 hours after ICU discharge.

Change in the thickness of the diaphragm and quadriceps femoris muscles.

Secondary Outcomes

  • Respiratory muscle thickness(At the end of data collection, within 24 hours after ICU discharge.)
  • Muscle thickness and functional outcomes(At the end of data collection, within 24 hours after ICU discharge.)
  • Grip strength and clinical outcomes(At the end of data collection, within 24 hours after ICU discharge.)
  • Mobility level correlation with clinical and functional outcomes(At the end of data collection, within 24 hours after ICU discharge.)

Study Sites (1)

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