- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05441657
Visualizing Regional Lung Ventilation in Patients With Postacute-COVID-19 (ViReVentPoCov)
Visualisation of Changes in Regional Ventilation in Dyspnoeic Postacute COVID-19 Patients: A Case-control Study Using Electrical Impedance Tomography (EIT)
Study Overview
Status
Detailed Description
When treating patients with dyspnoea, conventional diagnostic tools (computed tomography, spirometry, body plethysmography) often fail to detect pathological changes, making it difficult for the treating physician to choose an appropriate therapeutic approach. Therefore, it would be desirable to have an examination method that reveals the pulmonary changes in postacute Corona-Virus-Disease-2019 (COVID-19) syndrome (PCS) patients that remain hidden from other diagnostic procedures.
Electrical impedance tomography (EIT) is a non-invasive and radiation-free imaging technique that can show the regional ventilation of the lungs almost "in real-time" based on the changes in the electrical impedance of the thorax during inspiration and expiration. This method is based on the observation that the electrical conductivities of biological tissues vary considerably depending on their nature and functional state. Clinical questions in which the inhomogeneity of lung ventilation is to be analysed (e.g., under- or overinflation of individual lung areas, lung collapse, etc.) can be investigated particularly well with EIT since intrathoracic impedance changes correlate strongly with changes in regional lung ventilation.
Up to now, EIT has mainly been used as a monitoring method in intensive care medicine to adapt ventilation settings and other therapeutic measures to the individual needs of patients. In this field, the method has proven useful for obtaining an overview of the distribution of a respiratory volume in a transverse EIT slice, comparing different lung regions, identifying inhomogeneities and assessing regional ventilation during spontaneous breathing.
The aim of this case-control study is to use EIT data obtained during routine examinations of post-COVID patients to analyse whether patients with PCS show more distinct lung alterations than the control group. Maybe these lung alterations correlate with dyspnea most patients report subjectively.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Thuringia
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Jena, Thuringia, Germany, 07747
- Jena University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- for control group: no current lung diseases, over 18 years old
- for patients with postacute COVID-19 syndrome: over 18 years, positive SARS-CoV-2-PCR
Exclusion Criteria:
- heart pacemaker
- epilepsy
- BMI over 50
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
|---|
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dyspnoeic patients with post-acute COVID-19 syndrome
100 patients with/without persisting dyspnea after COVID-19 disease were examined by Electric Impedance Tomography (EIT).
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control group
50 healthy volunteers with no lung disease were voluntarily examined by Electric Impedance Tomography.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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pathogenic changes in regional lung ventilation
Time Frame: until July 2022
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pathogenic changes in regional lung ventilation considered
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until July 2022
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jan-Christoph Lewejohann, Dr.med., Jena University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Post-Infectious Disorders
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Pathological Conditions, Signs and Symptoms
- COVID-19
- Post-Acute COVID-19 Syndrome
Other Study ID Numbers
- KIM-IV-EIT-04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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