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COVID-19 Respiratory InfectionEMG-COVIDNCT05572853

Respiratory Muscles Electromyography in Patients With Covid-19

An observational study of COVID-19 Respiratory Infection, run by University of Pernambuco at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
COVID-19 Respiratory Infection
How many people
74 participants
Where
1 siteBrazil
Study dates
25 Feb 2021to 28 Aug 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Physical Therapy Department, Universidade Federal de Pernambuco

    Recife, Pernambuco, 50670-901

Other trials in Brazil

About this study

Official title: 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.

Read the 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)
Keywords
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
Medical subject headings
Coronavirus Infections, Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05572853
Study groupRoleWhat they receive
Classification of oxygenation status stratificationPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 10 minutes

  2. 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, scalene, diaphragm and rectus abdominis.

    Measured: 10 minutes

Secondary outcomes (1)

  1. 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.

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2022
  2. Study start25 Feb 2021
  3. Primary completion30 Dec 2022
  4. Study completion28 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05572853
Sponsor's protocol ID
42130821.9.3001.5200
Acronym
EMG-COVID
Status last verified
Mar 2024
First submitted
31 Jul 2022
Last updated
6 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Miralles R, Gamboa NA, Gutierrez MF, Santander H, Valenzuela S, Bull R, Fuentes AD, Cordova R. Effect of breathing type on electromyographic activity of respiratory muscles during tooth clenching at different decubitus positions. Cranio. 2019 Jan;37(1):28-34. doi: 10.1080/08869634.2018.1470274. Epub 2018 May 7.

    PubMed 29730974

  • Alonso JF, Mananas MA, Rojas M, Bruce EN. Coordination of respiratory muscles assessed by means of nonlinear forecasting of demodulated myographic signals. J Electromyogr Kinesiol. 2011 Dec;21(6):1064-73. doi: 10.1016/j.jelekin.2011.07.004. Epub 2011 Aug 6.

    PubMed 21821430

  • American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.

    PubMed 12186831

  • Apigo M, Schechtman J, Dhliwayo N, Al Tameemi M, Gazmuri RJ. Development of a work of breathing scale and monitoring need of intubation in COVID-19 pneumonia. Crit Care. 2020 Jul 31;24(1):477. doi: 10.1186/s13054-020-03176-y. No abstract available.

    PubMed 32736637

  • Beck J, Sinderby C, Lindstrom L, Grassino A. Diaphragm interference pattern EMG and compound muscle action potentials: effects of chest wall configuration. J Appl Physiol (1985). 1997 Feb;82(2):520-30. doi: 10.1152/jappl.1997.82.2.520.

    PubMed 9049732

  • Bissett B, Gosselink R, van Haren FMP. Respiratory Muscle Rehabilitation in Patients with Prolonged Mechanical Ventilation: A Targeted Approach. Crit Care. 2020 Mar 24;24(1):103. doi: 10.1186/s13054-020-2783-0.

    PubMed 32204719

  • Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

    PubMed 7154893

  • Cabanes-Martinez L, Villadoniga M, Gonzalez-Rodriguez L, Araque L, Diaz-Cid A, Ruz-Caracuel I, Pian H, Sanchez-Alonso S, Fanjul S, Del Alamo M, Regidor I. Neuromuscular involvement in COVID-19 critically ill patients. Clin Neurophysiol. 2020 Dec;131(12):2809-2816. doi: 10.1016/j.clinph.2020.09.017. Epub 2020 Oct 15.

    PubMed 33137571

  • Caruso P, Albuquerque AL, Santana PV, Cardenas LZ, Ferreira JG, Prina E, Trevizan PF, Pereira MC, Iamonti V, Pletsch R, Macchione MC, Carvalho CR. Diagnostic methods to assess inspiratory and expiratory muscle strength. J Bras Pneumol. 2015 Mar-Apr;41(2):110-23. doi: 10.1590/S1806-37132015000004474.

    PubMed 25972965

  • Cecchini J, Schmidt M, Demoule A, Similowski T. Increased diaphragmatic contribution to inspiratory effort during neurally adjusted ventilatory assistance versus pressure support: an electromyographic study. Anesthesiology. 2014 Nov;121(5):1028-36. doi: 10.1097/ALN.0000000000000432.

    PubMed 25208082

  • Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.

    PubMed 31986261

  • Chiti L, Biondi G, Morelot-Panzini C, Raux M, Similowski T, Hug F. Scalene muscle activity during progressive inspiratory loading under pressure support ventilation in normal humans. Respir Physiol Neurobiol. 2008 Dec 31;164(3):441-8. doi: 10.1016/j.resp.2008.09.010. Epub 2008 Oct 4.

    PubMed 18952011

  • Palacios Cruz M, Santos E, Velazquez Cervantes MA, Leon Juarez M. COVID-19, a worldwide public health emergency. Rev Clin Esp. 2021 Jan;221(1):55-61. doi: 10.1016/j.rce.2020.03.001. Epub 2020 Mar 20. English, Spanish.

    PubMed 32204922

  • Da Gama AE, de Andrade Carvalho L, Feitosa LA, do Nascimento Junior JF, da Silva MG, Amorim CF, Aliverti A, Lambertz D, Rodrigues MA, de Andrade AD. Acute effects of incremental inspiratory loads on compartmental chest wall volume and predominant activity frequency of inspiratory muscle. J Electromyogr Kinesiol. 2013 Dec;23(6):1269-77. doi: 10.1016/j.jelekin.2013.07.014. Epub 2013 Aug 11.

    PubMed 24035013

  • Daimon S, Yamaguchi K. Changes in respiratory activity induced by mastication during oral breathing in humans. J Appl Physiol (1985). 2014 Jun 1;116(11):1365-70. doi: 10.1152/japplphysiol.01236.2013. Epub 2014 Apr 17.

    PubMed 24744386

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 Respiratory Infection, run by University of Pernambuco at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Degree of dyspnea (time frame: 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05572853, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.

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