Respiratory Muscles Electromyography in Patients With Covid-19 (EMG-COVID)

March 4, 2024 updated by: Shirley Lima Campos, University of Pernambuco

Analysis of Electrical Activity of Respiratory Muscles in Patients Undergoing Oxygen Therapy With COVID-19: Cross-sectional Study

This research was characterized as a cross-sectional observational study, following the recommendations of the STROBE instrument. Therefore, it was conducted in the Intensive Care Unit of Otávio de Freitas Hospital (HOF) in Recife/PE, with patients over 18 years old who had a clinical diagnosis of COVID-19, using two methods of oxygen therapy (Nasal Oxygen Therapy) and (non-rebreather mask). Consequently, clinical evaluations were performed regarding the disease, severity of COVID-19, perception of respiratory effort, and electromyography of respiratory muscles.

  1. Leading Question: How does the recruitment pattern of diaphragmatic and extradiaphragmatic muscles in patients with acute hypoxemia caused by COVID-19 behave when assessed through EMGs, considering the SpO2/FiO2 ratio as the analysis parameter?
  2. Leading Question: Is there a relationship between the respiratory work estimated by electromyographic activity of diaphragmatic and extradiaphragmatic muscles in patients with acute hypoxemia due to COVID-19 and the parameters of respiratory frequency and levels of acute hypoxemia measured by the SpO2/FiO2 ratio?

The rationale for this study is that the COVID-19 pandemic has caused significant impacts on global public health due to the high volume of respiratory complications in the face of a limited supply of healthcare resources, consequently leading to high mortality. Complications are initially manifested by acute hypoxemia associated with COVID-19 infection, sometimes silent upon visual inspection or using less sensitive methods. This complicates the management of compensatory respiratory work for hypoxemia, even with oxygen therapy support. Respiratory muscle recruitment involves aspects of inspiratory effort and ventilatory mechanics. Recognizing the presence and recruitment pattern of muscles involved in a timely manner can contribute to the clinical management success rate of individuals affected by respiratory dysfunction associated with COVID-19, especially at different levels of acute hypoxemia. Surface electromyography is a non-invasive, low-risk tool compatible with the analysis of respiratory muscle recruitment patterns. However, there are no studies describing this pattern in COVID-19 patients, serving as a basis for personalized therapeutic strategies.

Study Overview

Status

Completed

Conditions

Detailed Description

  1. GENERAL OBJECTIVE To analyze the clinical aspects of surface electromyography of respiratory muscles in COVID-19 patients under different levels of hypoxemia.
  2. SPECIFIC OBJECTIVES To analyze the recruitment pattern of diaphragmatic and extradiaphragmatic muscles (sternocleidomastoid, scalene, and rectus abdominis) under different levels of acute hypoxemia in COVID-19 patients using the SpO2/FiO2 ratio as an analysis parameter and their relationships with clinical outcomes.
  3. STUDY SITE AND PERIOD This study was conducted in the Intensive Care Unit in the Severe Acute Respiratory Syndrome (SARS) sector of Otávio de Freitas Hospital (HOF), located in the city of Recife, Pernambuco - Brazil.
  4. SAMPLE The sample for this study consisted of spontaneously breathing patients admitted to the ICU diagnosed with COVID-19, who required low-flow oxygen therapy, using a nasal oxygen catheter or non-rebreathing mask.
  5. CLINICAL EVALUATION At the beginning, a comprehensive clinical assessment was carried out which included the following parameters: name, assessment date, date of birth, address, telephone contact, age (years), sex (male/female), weight (kg), height (cm ), Body Mass Index (BMI - weight, kg / height², m²), Heart Rate (HR - bpm), Respiratory Rate (RR - rpm) assessed through chest expansibility (assessed visually for 1 minute), Systolic Blood Pressure (SBP - in mmHg), Diastolic Blood Pressure (DBP - in mmHg), Mean Arterial Pressure (MAP), Peripheral Oxygen Saturation (SpO2), method of administration in oxygen therapy, medications in use, other diagnoses, length of stay in the ICU , as well as outcomes of tracheal intubation and death were analyzed prospectively.
  6. ASSESSMENT INSTRUMENTS Assessment of the severity of COVID-19 using the National Early Warning Score (NEWS2) and the Simplified Acute Physiological Score (SAPS3); Stratification of oxygenation status based on the relationship between blood oxygen saturation (SpO2) and the fraction of inspired oxygen (FiO2) SpO2/FiO2, divided into three categories: normal (> 315), mild to moderate (314 - 235) and severe (< 234); Assessment of the perception of respiratory effort using the modified Borg scale and assessment of respiratory work specific to COVID-19, which has been predicting the need for intubation; Evaluation of surface electromyography in the respiratory muscles, electrodes positioned in such a way that they aligned with the muscle fibers of the sternocleidomastoid, scalenes, diaphragm and rectus abdominis muscles.
  7. RESULTS Independently of the severity of hypoxemia, the observed pattern of muscle recruitment remained similar between the groups, with higher RMS values for the extradiaphragmatic muscles (scalene and sternocleidomastoid), followed by the diaphragm and rectus abdominis muscles, respectively. When comparing the SpO2/FiO2 groups, significant differences were observed in the scalene and sternocleidomastoid muscles. The scalene muscles showed lower activation in mild-moderate and severe cases compared to the normal group, while the sternocleidomastoid also exhibited reduced activation in mild-moderate cases compared to the normal group. However, no differences were identified in the recruitment level of the diaphragm and rectus abdominis muscles among the SpO2/FiO2 groups.
  8. ETHICAL ASPECTS This research project was approved by the Human Research Ethics Committee of the Federal University of Pernambuco (UFPE), where it complied with the postulates of the Declaration of Helsinki, following the terms recommended by the National Health Council (Resolution No. 466/ 2012) for research involving human subjects (approval number 4,560,383)

Study Type

Observational

Enrollment (Actual)

74

Contacts and Locations

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

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50670-901
        • Physical Therapy Department, Universidade Federal de Pernambuco

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

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The sample of this study consisted of patients admitted to the ICU with spontaneous breathing diagnosed with COVID-19, who required low-flow oxygen therapy, using a nasal oxygen catheter or non-rebreathing mask.

Description

Inclusion criteria:

  • Both genders
  • Age ≥ 18 years
  • Confirmed diagnosis for COVID-19 considering its positivity through the RT-PCR test
  • Patients who required low-flow oxygen therapy (nasal oxygen catheter or non-rebreathing mask)
  • Hemodynamic stability (heart rate between 60 - 149 bpm, systolic blood pressure ≤149/89 mmHg or diastolic ≥ 90/60 mmHg at the time of collection)
  • Body Mass Index ≤ 30 kg/m².

Exclusion criteria:

  • Anxiety and psychomotor agitation
  • Postural deformities (hyperlordosis, hyperkyphosis, lateral inclinations and antalgic postures)
  • Patients with chronic lung disease or diaphragmatic disorders
  • Undergoing surgical procedures on the spine
  • Neurological diseases that affect myoelectric conduction
  • Trauma or musculoskeletal injuries to the rib cage or respiratory muscles
  • Use of tracheostomy tubes
  • History of use of invasive mechanical ventilation during hospitalization (diagnosed and previously described in the electronic medical record)
  • Those who were using sedatives and bronchodilators, as well as a reduction in SpO2 during signal acquisition at the time of collection.

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

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Classification of oxygenation status stratification
Patients were classified into 3 groups with stratification of oxygenation status based on the relationship between blood oxygen saturation (SpO2) and fraction of inspired oxygen (FiO2) SpO2/FiO2, divided into three categories: normal (> 315), mild to moderate (314 - 235) and severe (< 234).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of dyspnea
Time Frame: 10 minutes
Evaluate the degree of dyspnea using the modified Borg scale, which characterizes the respiratory fatigue reported by patients, characterizing the degree of dyspnea with scores from 0 to 10, where 0 is (no discomfort) and a maximum score of 10 (maximum discomfort).
10 minutes
Level of activation of respiratory muscles
Time Frame: 10 minutes
As a way of analyzing the level of activation and fatigue of the respiratory muscles, surface electromyography (EMGS) was used in the respiratory muscles, analyzed using a surface electromyography, and the following muscles were evaluated: Sternocleidomastoid, scalene, diaphragm and rectus abdominis.
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the perception of respiratory effort in COVID-19
Time Frame: 10 minutes
Assessing the perception of respiratory effort through a validated instrument to assess the work of breathing in COVID-19 (Apigo et al., 2020) has been predicting the need for orotracheal intubation, associating respiratory rate, nasal flaring and use of accessory respiratory muscles.
10 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the severity of COVID -19
Time Frame: 10 minutes

To describe the severity of COVID -19 given by the National Early Warning Score (NEWS2) scale in three categories: Low risk (between 0 and 4 points), medium risk (between 5 and 6 points) and high risk greater (than 7 points).

The assessment called Simplified Acute Physiological Score (SAPS3) aims to analyze the severity of the disease during the ICU stay, consisting of previous data on the health status, complications that led to hospitalization, information related to the physiological and laboratory tests during the ICU stay.
10 minutes

Collaborators and Investigators

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

Sponsor

University of Pernambuco

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordination for the Improvement of Higher Education Personnel
Pernambuco Research Foundation (FACEPE)

Investigators

  • Principal Investigator: Emanuel Fernandes Ferreira da silva Júnior, Universidade Federal de Pernambuco

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)

February 25, 2021

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

August 28, 2023

Study Registration Dates

First Submitted

July 31, 2022

First Submitted That Met QC Criteria

October 7, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 42130821.9.3001.5200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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