ViReVentPoCov: Visualizing Regional Lung Ventilation in Patients With Postacute-COVID-19

Sponsor
Jena University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05441657
Collaborator
(none)
20
1
5.3
3.8

Study Details

Study Description

Brief Summary

In the absence of data on Electric impedance tomography of healthy spontaneous breathing patients that is compared to dyspnoeic patients suffering from postacute COVID-19 syndrome, the investigators contend that electrical impedance tomography provides additional clues to visualize regional lung ventilation and differentiate healthy from sick patients.

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 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 EIT is suitable as a radiation-free, non-invasive imaging technique for assessing regional ventilation of the lung in spontaneously breathing post-COVID patients and whether additional evidence of regional ventilation disorders in these patients can be found by determining lung ventilation using EIT. As there are no reference data from spontaneously breathing lung-healthy patients so far, a reference group will be generated whose EIT data will be compared with those of post-COVID patients.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Visualisation of Changes in Regional Ventilation in Dyspnoeic Postacute COVID-19 Patients: A Case-control Study Using Electrical Impedance Tomography (EIT)
Actual Study Start Date :
May 21, 2022
Actual Primary Completion Date :
Jul 8, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm Intervention/Treatment
dyspnoeic patients with post-acute COVID-19 syndrome

Patients with persisting dyspnoeic symptoms after COVID-19 disease were examined by Electric Impedance Tomography (EIT).

control group

Healthy volunteers with no lung disease and non-smokers were voluntarily examined by Electric Impedance Tomography.

Outcome Measures

Primary Outcome Measures

  1. pathogenic changes in regional lung ventilation [until July 2022]

    pathogenic changes in regional lung ventilation considered

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • for control group: no lung diseases, no allergic symptoms, non-smokers, over 18 years old

  • for patients with postacute COVID-19 syndrome: over 18 years, dyspnoeic symptoms

Exclusion Criteria:
  • heart pacemaker

  • epilepsy

  • BMI over 50

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jena university hospital Jena Thuringia Germany 07747

Sponsors and Collaborators

  • Jena University Hospital

Investigators

  • Study Director: Jan-Christoph Lewejohann, Dr.med., Jena University Hospital

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Jena University Hospital
ClinicalTrials.gov Identifier:
NCT05441657
Other Study ID Numbers:
  • KIM-IV-EIT-04
First Posted:
Jul 1, 2022
Last Update Posted:
Jul 12, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jena University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2022