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Completed

NCT Number: NCT03746795

Spirometry Using Electrical Impedance Tomography

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.

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Key information

Conditions

Healthy

Age range

18 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biomedical Technology Faculty of Biomedical Engineering Czech Technical University in Prague

Kladno, Czech Republic, 272 01, Czechia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spirometric examinations realized using the EIT

Device

Spirometric examinations will be realized using the EIT alone.

Simultaneous measurement by spirometer and EIT

Device

Spirometric examinations will be realized using the simultaneous measurement by spirometer and EIT

Primary outcomes

  1. FVC

    Time frame: through study completion, an average of 1 year

    forced vital capacity (L)

  2. FEV1

    Time frame: through study completion, an average of 1 year

    forced expiratory volume exhaled in the first second of a forced expiration (L)

  3. TI

    Time frame: through study completion, an average of 1 year

    ratio of FEV1/FVC called Tiffeneau index (-)

Sponsors and collaborators

Lead sponsor

Czech Technical University in Prague

Other

Registry information

Official study title

Realization of Spirometry Measurement Using Electrical Impedance Tomography (EIT)

Acronym: EIT

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Nov 20, 2018
Registry last updated
Mar 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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