Analysis of Breathing Pattern Post COVID-19

Covid19 Clinical Trial

Official title:

Applicability of New "Respiratory Diagnostic Assistant" Device in the Multidimensional Evaluation of Post-COVID-19 Respiratory Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05659615
• Other study ID #: 44382120.3.0000.5208
• Secondary ID: 4.666.483
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: February 10, 2023

Study information

• Verified date: December 2022
• Source: University of Pernambuco
• Contact: Shiley L Campos, PhD
• Phone: +55 (81) 2126-8492
• Email: shirley.campos[@]ufpe.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The sample will consist of volunteers with laboratory confirmed COVID-19 results who have SARS COV 2 variants tracked by the epidemiological surveillance of Caruaru-Pernambuco and will be recruited by coexistence in a non-probabilistic way. The sample study will be obtained through data provided by the municipal health department of the city of Caruaru-Pernambuco with a predicted sample of 131 people. In order to minimize sample losses, 10% will be added to the total sample, which corresponds to 144 participants. The software that can be used is known as GPower (version 3.13 for Windows) considering a statistical power (β) of 80% and a significance level (α) of 5%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 10, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• Study will not have intervention
Study will not have intervention

Locations

Country	Name	City	State
Brazil	Federal University of Pernambuco Department of Physiotherapy	Recife	PE

Sponsors (3)

Lead Sponsor	Collaborator
Shirley Lima Campos	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Six-minute walk test	Evaluation of functional capacity, through submaximal effort, through data obtained during a six-minute walk. The pre-test and post-test variables were measured: BORG scale (scale from 0 to 10); Perceived Effort (scale from 6 to 20); Peripheral Oxygen Saturation (%); Heart rate (measured in beats per minute); Respiratory Rate (measured by breaths per minute); Blood Pressure (mmHg); Distance Traveled (measured in meters); Expected Distance (%)	"Until the Completion of the Study, On Average 1 Year"
Other	Palmar Grip Strength	Assessment of handgrip strength through the dynamometry, measuring grip strength in a total of three repetitions, taking into account the greatest strength obtained in kilograms (kg/f)	"Until the Completion of the Study, On Average 1 Year"
Primary	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"
Primary	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	Lung Function	Lung function tests are usually performed with computerized systems that analyze the data and provide immediate results.; The spirometer associates variables capable of tracing a functional diagnosis of the respiratory system: Forced vital capacity (FVC) (measured in liters); Forced expiratory volume in 1 second - (FEV1) (measured in liters); Relationship between forced vital capacity (FVC) and; Forced expiratory volume in 1 second - (FEV1); Functional Diagnosis: Normal; Obstructive ventilatory disorder (mild, moderate or severe); Restrictive ventilatory disorder (mild, moderate or severe); Mixed ventilatory disorder (with detection of obstructive and restrictive abnormality)	"Until the Completion of the Study, On Average 1 Year"
Secondary	Assessment of lung volumes and capacities by ventilometry	Non-invasive analogue assessment of lung volumes and capacities, easy to understand, with quantitative variables; Respiratory rate (RR) (measured in incursion per minute) Minute volume (MV), (measured in liters) Tidal volume (TV), (measured in liters) Inspiratory capacity (IC) (measured in liters) Vital capacity (CL) (measured in liters)	"Until the Completion of the Study, On Average 1 Year"
Secondary	Maximum inspiratory pressure (Manuvacuometry)	Manuvacuometry: Non-invasive measurement of inspiratory muscle pressure.; Maximum inspiratory pressure (MIP measured in cmH2O); Maximum predicted inspiratory pressure (MIP predicted %)	"Until the Completion of the Study, On Average 1 Year"
Secondary	Maximum expiratory pressure (Manuvacuometry)	Manuvacuometry: Non-invasive measurement of inspiratory muscle pressure.; Maximum expiratory pressure (MEP - cmH2O); Maximum predicted expiratory pressure (MEP predicted %)	"Until the Completion of the Study, On Average 1 Year"