Covid19NCT05659615
Analysis of Breathing Pattern Post COVID-19
An observational study of Covid19, run by Shirley Lima Campos at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Covid19
- What is being tested?
- Study will not have intervention
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2020to 10 Feb 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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;
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Pernambuco Department of Physiotherapy
Recife, Pernambuco, 50740-560
Shirley L Campos, 1, + 55 8199413087, shirley.campos@ufpe.br
Jakson H Silva, 2, +55 81 999643502, jakson.silva@ufpe.br
About this study
Official title: Applicability of New "Respiratory Diagnostic Assistant" Device in the Multidimensional Evaluation of Post-COVID-19 Respiratory Function
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.
Read the detailed 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%.
- Conditions
- Covid19
- Being tested
- Study will not have intervention
- Keywords
- COVID-19, Diagnosis, Physiotherapy, Breathing Pattern
- Medical subject headings
- COVID-19, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study will not have interventionOther
Study will not have intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "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.
Measured: "Until the Completion of the Study, On Average 1 Year"
Secondary outcomes (4)
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)
Measured: "Until the Completion of the Study, On Average 1 Year"
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)
Measured: "Until the Completion of the Study, On Average 1 Year"
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 %)
Measured: "Until the Completion of the Study, On Average 1 Year"
Maximum expiratory pressure (Manuvacuometry)
Manuvacuometry: Non-invasive measurement of inspiratory muscle pressure.
- Maximum expiratory pressure (MEP - cmH2O)
- Maximum predicted expiratory pressure (MEP predicted %)
Measured: "Until the Completion of the Study, On Average 1 Year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Sep 2020
- Primary completion20 Dec 2022 (estimated)
- Study completion10 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Lima Campos
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Universidade Federal de Pernambuco
- Responsible party
- Sponsor-investigator, Shirley Lima Campos, University of Pernambuco
- Investigators
- Shirley L Campos, Phd, Study director, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659615
- Sponsor's protocol ID
- 44382120.3.0000.5208
- Other IDs
- 4.666.483
- Status last verified
- Dec 2022
- First submitted
- 1 Nov 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Não: Não há um plano para disponibilizar o IPD
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applicability of New "Respiratory Diagnostic Assistant" Device in the Multidimensional Evaluation of Post-COVID-19 Respiratory Function
- ClinicalTrials.gov ID
- NCT05659615
- Acronym / sponsor ID
- 44382120.3.0000.5208
- Conditions
- Covid19
- Keywords
- COVID-19, Diagnosis, Physiotherapy, Breathing Pattern
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shirley Lima CamposUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Universidade Federal de Pernambuco
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 10 Feb 2023 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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%.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study will not have interventionStudy will not have intervention | Other | – |
Primary outcome
Breathing pattern diagnosis
Time frame: "Until the Completion of the Study, On Average 1 Year"
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.
Breathing pattern variables
Time frame: "Until the Completion of the Study, On Average 1 Year"
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.
4 secondary outcomes
Lung Function
Time frame: "Until the Completion of the Study, On Average 1 Year"
Assessment of lung volumes and capacities by ventilometry
Time frame: "Until the Completion of the Study, On Average 1 Year"
Maximum inspiratory pressure (Manuvacuometry)
Time frame: "Until the Completion of the Study, On Average 1 Year"
Maximum expiratory pressure (Manuvacuometry)
Time frame: "Until the Completion of the Study, On Average 1 Year"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: No. Não: Não há um plano para disponibilizar o IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirley L Campos, Phd study director
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Shirley Lima Campos 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiley L Campos, PhD (+55 (81) 2126-8492, shirley.campos@ufpe.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathing pattern diagnosis (time frame: "Until the Completion of the Study, On Average 1 Year"). 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?
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 21 Dec 2022.