Respiratory Muscles Electromyography in Patients With Covid-19

Study Overview
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Brief Summary
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This research is characterized as a cross-sectional observational study, which follows the recommendations of the STROBE instrument. Therefore, it is being performed at the Intensive Care Unit of Hospital Otávio de Freitas (HOF) in Recife/PE, with patients over 18 years of age who have a clinical diagnosis of COVID-19, using two methods of oxygen therapy (Nasal Oxygen Catheter and mask without rebreathing). That through clinical assessments of the disease, degree of severity of COVID-19, perception of respiratory effort and electromyography of respiratory muscles. The hypothesis of this study is that the higher the level of muscle activation and fatigue, the greater the risk of intubation and length of stay in the ICU. The rationale for the study is that Surface Electromyography is a widely used resource to analyze and compare respiratory muscle responses and thus provide prior treatment. Identifying which muscles undergo changes in patients with COVID-19 is essential to analyze and understand the likely functional changes of the respiratory system in COVID-19 and how they reflect according to their level of respiratory support and disease severity.

Detailed Description
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GENERAL PURPOSE To analyze and compare the surface electromyographic signals of the respiratory muscles during oxygen therapy support in patients with COVID-19 admitted to the ICU. SPECIFIC OBJECTIVES To analyze the characteristics of the study participants, namely: age, sex, weight, height, BMI, comorbidities, medications in use, modified national early warning score (NEWS) for COVID and length of stay in the ICU; To analyze the severity of the disease during the ICU stay using the Simplified Acute Physiological Score Scale - SAPS3; To evaluate and compare values obtained from the RMS of the respiratory muscles: sternocleidomastoid (SCM), scalene (ESC), Diaphragm (DI) and rectus abdominis (RA) by means of surface electromyography (EMGs). To analyze and compare respiratory muscle fatigue using the Fast Fourier Transform (FFT) equation with the median value in the analysis of the frequency domain of surface electromyography in respiratory muscles; Correlate the Borg scale and the COVID respiratory work scale with RMS values of EMGs of respiratory muscles in spontaneous breathing with oxygen therapy; Analyze Respiratory Rate (RR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Blood Pressure (MAP), Heart Rate (HR) and Oxygen Saturation in arterial blood (SpO2). PLACE AND PERIOD OF THE STUDY The present moment is being carried out in the Intensive Care Unit of the SARS sector of Hospital Otávio de Freitas (HOF), Recife/PE, from February 2021 to November 2022. SAMPLE The sample is composed of volunteers with COVID-19 admitted to the SRAG ICU of Hospital Otávio de Freitas - Recife. Remaining the same in the use of oxygen therapy in spontaneous breathing, the oxygen therapy method was divided into two categories, these being the use of nasal catheter and non-rebreathing mark. ELIGIBILITY CRITERIA The sample is composed of individuals of both sexes, aged over 18 years; individuals who had a confirmed diagnosis for COVID-19 considering their positivity by the RT-PCR exam; no restrictions on the length of stay in the ICU; who had clinical stability at the time of collection and body mass index (BMI) < or equal to 30. Those who had deformities that compromised the mechanics of the locomotor system were excluded; seizures, psychomotor agitation, delirium, and anxiety that prevented the assessment excursion; COPD patients; use of a cardiac pacemaker; any surgical procedure on the spine; diaphragmatic diseases; spinal cord injuries; musculoskeletal trauma or injuries to the rib cage or respiratory muscles; cardiovascular and neurological comorbidities; appearance of skin lesions, colostomy bag, infection or tumor in the application area, collections that showed interference in the myoelectric signal, even after several collection attempts. CLINICAL EVALUATION Initially, the clinical evaluation is being carried out, consisting of: name, evaluation date, date of birth, address, telephone contact, age (years), sex (male/female), weight (kg), height (cm), index of body mass - BMI (weight/height²), Heart Rate - HR (bpm), Respiratory Rate - RR (irpm), visually assessed by chest expansion for 1 minute, Systolic Blood Pressure (SBP) in (mmHg), Diastolic Blood Pressure (DBP) )) in (mmHg), Mean Blood Pressure (MAP), Peripheral Oxygen Saturation (SpO2), form of administration in oxygen therapy, medications in use, other diagnoses, EMG collection values and during the research the time of ICU admission. ASSESSMENT INSTRUMENTS Assessment of the severity of COVID-19 through the National Early Warning Score (NEWS2) and the Simplified Acute Physiological Score (SAPS3); Assessment of the perception of respiratory effort through the modified Borg Scale and Assessment of Work Breathing in Covid-19, where it has been predicting the need for intubation; Evaluation of surface electromyography (EMGS) in respiratory muscles, where the level of aviation and muscular fatigue of the respiratory muscles will be analyzed, namely: Sternocleidomastoid (SCM), scalene (ESC), Diaphragm (DI) and rectus abdominis (RA) EXPECTED RESULTS Hope that after analyzing the respiratory muscle surface electromyography data in the ICU, they will contribute to the scientific community, in factors related to intubation and length of stay in the ICU. In addition, it is critical to analyze and understand the likely functional changes of the respiratory system in COVID-19 and how they reflect according to their level of respiratory support and disease severity. ETHICAL ASPECTS The Research Research Committee was approved by the Ethics Committee in Research with Human Beings of the Hospital Otávio de Freitas, where it met the postulates of the Declaration of Helsinki, a project amended in Edinburgh in 2000, following the terms recommended by the National Health Council (Resolution n. 466/) 2012 ) for research in human beings, under opinion number 4,626,902 and CAAE: 42130821.9.3001.5200.

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

Conditions
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COVID-19 Respiratory Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals of both genders; Age group over 18 years old; Individuals who had a confirmed diagnosis for COVID-19 considering their positivity through the RT-PCR exam; No ICU admission period restrictions; Who had clinical stability: heart rate less than 149 bpm, blood pressure < 149/89 mmHg or > 90/60 mmHg at the time of collection; Body Mass Index (BMI) < or equal to 30. Exclusion Criteria: Those who had deformities that compromised the mechanics of the locomotor system; Seizures, psychomotor agitation, delirium and anxiety that prevented the assessment excursion; Patients with COPD; Use of cardiac pacemaker; Any surgical procedure on the spine; Diaphragmatic diseases; spinal cord injuries; Traumas or musculoskeletal injuries to the rib cage or respiratory muscles; Cardiovascular and neurological comorbidities; Appearance of skin lesions; Colostomy bag; Infection or tumor in the application area; Collections that showed interference in the myoelectric signal, even after several collection attempts.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Spontaneous breathing patients with COVID-19 in the ICU using oxygen therapy<br>The group of patients using oxygen therapy were breathing spontaneously, and they were divided into two aspects as the form of oxygen administration, which remained in a nasal catheter and non-rebreathing mask. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of dyspnea | 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 | 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 (ECM), scalene (ESC), Diaphragm (DI) and rectus abdominis (RA). | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the perception of respiratory effort in COVID-19 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surface electromyography, EMGs, electromyography, coronavirus 2, SARS-CoV-2, Coronavirus, Intensive care unit, ICU, critically ill, Risk of orotracheal intubation, respiratory muscle fatigue, breathing muscles, EMG, COVID-19 Respiratory Infection