Spirometry Using Electrical Impedance Tomography (EIT)

March 8, 2019 updated by: Czech Technical University in Prague

Realization of Spirometry Measurement Using Electrical Impedance Tomography (EIT)

The main aim of this study is to test spirometry measurements using EIT with a calibration using tidal volume obtained from the simultaneous standard spirometry measurement. Another goal is to compare, based on the calibration, the spirometry parameters obtained from separate measurements using EIT and the standard spirometry using a pneumotachograph.

All spirometry measurements will be conducted in accordance with the latest available standards of the American Thoracic Society (ATS) and European Respiratory Society (ERS) from the year 2005, including their emendation from 2017.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adding the pneumotachograph and antibacterial filter to the respiratory system can lead to increased dead space, flow resistance, and change the respiratory pattern. All of these negative features and reduced patient co-operation affect the measured results and their interpretation. The aim of this study is to test spirometry measurement using EIT and evaluate such spirometry parameters as forced vital capacity (FVC), forced expiratory volume exhaled in the first second of a forced expiration (FEV1) and ratio of FEV1/FVC called Tiffeneau index (TI) based on recalculation using the calibration constant. The study will be conducted using Ergostik (Geratherm, Germany) spirometer and EIT system Pulmovista 500 (Dräger, Germany).

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

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

  • Czechia
    • Czech Republic
      • Kladno, Czech Republic, Czechia, 272 01
        • Department of Biomedical Technology Faculty of Biomedical Engineering Czech Technical University in Prague

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 to 28 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males and females > 18 years old
  • Signed informed consent has been obtained

Exclusion Criteria:

  • Pregnancy
  • Cardiac pacemakers
  • Electrically active implant
  • Critical illness
  • Intrathoracic metal implants
  • Value of body mass index (BMI)>50

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard spirometry
Standard spirometry measurement with a pneumotachograph alone.
Experimental: EIT alone
Spirometric examinations realized using the EIT
Device: Spirometric examinations realized using the EIT
Spirometric examinations will be realized using the EIT alone.
Experimental: Simultaneous standard spirometry and EIT
Simultaneous measurement by spirometer and EIT
Device: Simultaneous measurement by spirometer and EIT
Spirometric examinations will be realized using the simultaneous measurement by spirometer and EIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FVC
Time Frame: through study completion, an average of 1 year
forced vital capacity (L)
through study completion, an average of 1 year
FEV1
Time Frame: through study completion, an average of 1 year
forced expiratory volume exhaled in the first second of a forced expiration (L)
through study completion, an average of 1 year
TI
Time Frame: through study completion, an average of 1 year
ratio of FEV1/FVC called Tiffeneau index (-)
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Czech Technical University in Prague

Investigators

  • Principal Investigator: Karel Roubík, prof., Czech Technical University in Prague, FBMI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 27, 2017

Primary Completion (Actual)

January 30, 2018

Study Completion (Actual)

March 8, 2019

Study Registration Dates

First Submitted

November 13, 2018

First Submitted That Met QC Criteria

November 16, 2018

First Posted (Actual)

November 20, 2018

Study Record Updates

Last Update Posted (Actual)

March 11, 2019

Last Update Submitted That Met QC Criteria

March 8, 2019

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EITspiro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

EIT anonymous images and corresponding spirometry data.

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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