Muscle Evaluation of Patients Infected by the Coronavirus

October 5, 2021 updated by: Hospital Israelita Albert Einstein

Muscle Evaluation of Patients Infected by the Coronavirus Requiring Mechanical Ventilation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 05652-900
        • Recruiting
        • Hospital israelita Albert Einstein
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Aléxia G Viana, PT
        • Sub-Investigator:
          • Ana C Lazarin, PT
        • Sub-Investigator:
          • Bárbara A Bento, PT
        • Sub-Investigator:
          • Bianca M Garcia, PT MSc
        • Sub-Investigator:
          • Blenda N Caldeira, PT
        • Sub-Investigator:
          • Caroline G Mól, PT
        • Sub-Investigator:
          • Cilene S Silva, PT
        • Sub-Investigator:
          • Emanuel S Pereira, PT
        • Sub-Investigator:
          • Carlos M Calcia, PT
        • Sub-Investigator:
          • Érika M Almeida
        • Sub-Investigator:
          • Felipe F Rodrigues, PT
        • Sub-Investigator:
          • Janaína A Mattos
        • Sub-Investigator:
          • Flavia S Leite, PT MSc
        • Sub-Investigator:
          • Gustavo B Marcelino, PT
        • Sub-Investigator:
          • Jefferson S Bassi, PT
        • Sub-Investigator:
          • Karina T Timenetsky, PT MSc PhD
        • Sub-Investigator:
          • Marcel Y Ferreira, PT
        • Sub-Investigator:
          • Renata L Pereira, PT
        • Sub-Investigator:
          • Renato B Reis, PT
        • Principal Investigator:
          • Ricardo K Nawa, PT MSc PhD
        • Sub-Investigator:
          • Ricardo L Cordioli, MD PhD
        • Sub-Investigator:
          • Rogerio Dib, PT
        • Sub-Investigator:
          • Thiago C Domingos, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

SARS-CoV-2 patients admitted to the intensive care unit requiring invasive mechanical ventilation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ultrasound assessment
Muscle ultrasound evaluation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1, 5, and within 24 hours after ICU discharge.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory muscle thickness
Time Frame: At the end of data collection, within 24 hours after ICU discharge.
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
Time Frame: 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).
At the end of data collection, within 24 hours after ICU discharge.
Grip strength and clinical outcomes
Time Frame: 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).
At the end of data collection, within 24 hours after ICU discharge.
Mobility level correlation with clinical and functional outcomes
Time Frame: 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).
At the end of data collection, within 24 hours after ICU discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Israelita Albert Einstein

Investigators

  • Study Chair: Caroline G Mól, PT, Hospital israelita Albert Einstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 30, 2021

Primary Completion (ANTICIPATED)

September 1, 2022

Study Completion (ANTICIPATED)

September 1, 2022

Study Registration Dates

First Submitted

September 4, 2021

First Submitted That Met QC Criteria

September 20, 2021

First Posted (ACTUAL)

October 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2021

Last Update Submitted That Met QC Criteria

October 5, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49075421.0.0000.0071
  • 4.923.576 (OTHER: Hospital Israelita Albert Einstein Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) collected during the study that underlie results reported will be shared after de-identification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Data will be available at the end of the study, as soon as the manuscript became published in a journal (following publication). No end date (data will be available indefinitely).

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal and/or investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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