Imbalances of Regional Pulmonary Ventilation in Patients With Post-acute-COVID-19

March 13, 2024 updated by: Jena University Hospital

Imbalances of Regional Pulmonary Ventilation in Patients With Post-acute-COVID-19 Symptoms

Investigation of the correlation of CT-morphological changes of the lung compared to regional ventilation distribution on electrical impedance tomography in patients with post-acute-Covid-19 symptoms.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Prospective non-interventional, monocentric observational study on imbalances in regional lung ventilation compared to chest CT in post-acute-Covid-19. The aim is to verify the agreement between computerized tomography derived imaging variables and electrical impedance tomography in detecting lung ventilation imbalances. The primary study objective is to match CT morphological changes in regional ventilation in post-acute-COVID-19 patients and/or changes in lung function examination, with changes that can be visualized by electroimpedance tomography.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • Klinik für Notfallmedizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All patients presenting to the post-COVID-19 outpatient clinic are screened.

Description

Inclusion Criteria:

  • all patients undergoing a Chest CT due to suspected post-acute-Covid-19-syndrome
  • >18 years
  • informed consent.

Exclusion Criteria:

  • trauma patients and patients with unstable spinal injuries or fractures
  • patients with an BMI over 50
  • patients with uncontrolled body movements
  • Patients with a pacemaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control cohort
lung-healthy volunteers get a EIT measurement
Case cohort
Patients who receive standard CT and pulmonary function testing also receive electroimpedance tomography measurement
Diagnostic test: additional EIT Measurement
Patients who receive standard CT and pulmonary function testing also receive electroimpedance tomography measurement. The lunghealthy Patients in the control group only receive a EIT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between tomography and electroimpedance tomography
Time Frame: until May 2022
The primary study objective is to match CT morphological changes in regional ventilation in post-COVID patients and/or changes in lung function examination with changes that can be visualized by electroimpedance tomography.
until May 2022

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between lung function testing and electroimpedance tomography
Time Frame: until May 2022
until May 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jena University Hospital

Investigators

  • Study Director: Phillip A Reuken, Dr., Jena University Hospital, Klinik für Innere Medizin IV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

February 8, 2022

First Submitted That Met QC Criteria

February 11, 2022

First Posted (Actual)

February 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIM-IV-EIT03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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