Respiratory Muscles Electromyography in Patients With Covid-19

NCT05572853 | Completed DMC

• 1 other identifier: 42130821.9.3001.5200
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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 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. 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. 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?

Conditions

COVID-19 Respiratory Infection

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

Outcome Measures

Primary Outcomes (2)

• 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, scalene, diaphragm and rectus abdominis.

  10 minutes

Secondary Outcomes (1)

• Assessment of the perception of respiratory effort in COVID-19

  10 minutes

Other Outcomes (1)

• Assessment of the severity of COVID -19

  10 minutes

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pernambuco: lead
• Coordination for the Improvement of Higher Education Personnel: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Fundação de Amparo à Ciência e Tecnologia de Pernambuco: collaborator

Study Sites (1)

Physical Therapy Department, Universidade Federal de Pernambuco

Recife, Pernambuco, 50670-901, Brazil

Location

Related Publications (26)

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MeSH Terms

Conditions

Coronavirus Infections; Critical Illness

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emanuel Fernandes Ferreira da silva Júnior

  Universidade Federal de Pernambuco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: October 10, 2022
• Study Start: February 25, 2021
• Primary Completion: December 30, 2022
• Study Completion: August 28, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)