Analysis of Breathing Pattern Post COVID-19

NCT05659615 | Unknown

• 2 other identifiers: 44382120.3.0000.52084.666.483
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The COVID-19 pandemic, a disease caused by the SARS-CoV-2 virus, has generated an inexplicable scenario for global health, causing different complications and degrees of functional impairment in millions of people who manage to recover from the disease. The respiratory system is the main system to be directly impacted during COVID-19 infection, and its treatment can generate changes in the respiratory function of individuals surviving the exacerbation of the disease, which may promote subjective and quantitative changes in the respiratory pattern, requiring an evaluation with high-cost instruments, an evaluation necessary to outline a better planning therapeutic for this population. The goal of this study is evaluate the breathing pattern variables using a device called RESPIRATORY DIAGNOSTIC ASSISTANT (RDA) and verify the relationship between the breathing pattern variables with the variables of pulmonary function, respiratory muscle strength and respiration in patients after involvement by COVID-19. This is a observational and validation study, prospective with follow-up of respiratory function for 6 months, a subproject linked to the project already approved by the research ethics committee under opinion: 4.362.977/4.596.02. Data collection will be carried out in a single day and divided into a few steps that will take place at the cardiopulmonary physiotherapy laboratory located at the physiotherapy department of the Federal University of Pernambuco. The first step is to conduct an interview with the participants to collect clinical data and perform a physical examination. Subsequently, a multidimensional evaluation of respiratory function will be performed. Statistical analysis will be performed using the Statistical Package For Social Science (SPSS) software version 20.0 for Windows. The Kolmogorov-Smirnov test will be used to verify the type of distribution, regarding the normality of the variables, and the significance level adopted will be 95% (α \<0.05) for all analyses. Finally, the data obtained will be presented in tables and/or graphs.

Conditions

Covid19

Keywords

COVID-19; Diagnosis; Physiotherapy; Breathing Pattern

Outcome Measures

Primary Outcomes (2)

• Breathing pattern diagnosis

  The algorithm of the "Respiratory Diagnostic Assistant" device relates the variables respiratory rate, tidal volume, minute volume, inspiratory flow, expiratory flow, relationship between inspiratory and expiratory times, providing classification of breathing pattern during rest breathing. The "Respiratory Diagnosis Assistant" algorithm provides through graphs allowing the classification of the diagnosis in normal or altered. * Normal breathing pattern described in frequency of cases. It is defined no changes by the algorithm of the "Respiratory Diagnostic Assistant". * Altered breathing pattern described in frequency of cases. It is defined by changing the breathing pattern variables captured by the flow sensor of the "Respiratory Diagnostic Assistant" device during breathing at rest.

  "Until the Completion of the Study, On Average 1 Year"

• Breathing pattern variables

  The algorithm of the "Respiratory Diagnostic Assistant" device relates the variables respiratory rate, tidal volume, minute volume, inspiratory flow, expiratory flow, relationship between inspiratory and expiratory times. The variables of the breathing pattern will also be quantitatively evaluated:: * Respiratory rate in incursion per minute * Tidal volume (measured in liters) * Minute volume (measured in liters); * Inspiratory flow (measured in liters); * Expiratory flow (measured in liters); * Ti/Ttotal, (measured in segunds) * I:E , relationship between inspiratory and expiratory times * Volume vs time; * Flow vs time.

  "Until the Completion of the Study, On Average 1 Year"

Secondary Outcomes (4)

• Lung Function

  "Until the Completion of the Study, On Average 1 Year"

• Assessment of lung volumes and capacities by ventilometry

  "Until the Completion of the Study, On Average 1 Year"

• Maximum inspiratory pressure (Manuvacuometry)

  "Until the Completion of the Study, On Average 1 Year"

• Maximum expiratory pressure (Manuvacuometry)

  "Until the Completion of the Study, On Average 1 Year"

Other Outcomes (2)

• Six-minute walk test

  "Until the Completion of the Study, On Average 1 Year"

• Palmar Grip Strength

  "Until the Completion of the Study, On Average 1 Year"

Interventions

Study will not have intervention OTHER

Study will not have intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population will consist of patients of both sexes, aged over 18 years, who had a confirmed diagnosis of the new coronavirus (COVID-19) through laboratory tests such as the molecular biology test (RT-PCR) or serological. This sample will be matched by 90 individuals according to sex and age group without a confirmed diagnosis of COVID-19 and with a self-report of absence of symptoms related to COVID-19

You may qualify if:

• Older than 18 years;
• Diagnosed with COVID-19;
• After the period of home isolation or hospital discharge;
• More than 40 days without the presence of symptoms associated with COVID-19;

You may not qualify if:

• Participants who are unable to perform the assessment tests or who present contraindications to the assessment of respiratory function;
• Those patients who prove reinfection by the new Coronavirus;
• Pregnant patients;
• Refusal to sign the Free and Informed Consent Form (FICF)

Sponsors & Collaborators

• Shirley Lima Campos: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Universidade Federal de Pernambuco: collaborator

Study Sites (1)

Federal University of Pernambuco Department of Physiotherapy

Recife, Pernambuco, 50740-560, Brazil

RECRUITING

MeSH Terms

Conditions

COVID-19; Disease

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shirley L Campos, Phd

  Universidade Federal de Pernambuco

  STUDY DIRECTOR

Central Study Contacts

Shiley L Campos, PhD

CONTACT

+55 (81) 2126-8492; shirley.campos@ufpe.br

JAKSON H SILVA, Esp

CONTACT

+55 (81) 2126-8492; jakson.silva@ufpe.br

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: December 21, 2022
• Study Start: September 1, 2020
• Primary Completion: December 20, 2022
• Study Completion: February 10, 2023
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)