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Completed

NCT Number: NCT06419790

Effect of Electrode Belt Used for Lung Monitoring With EIT on Tidal Volume

Tidal volumes of ten spontaneously breathing healthy volunteers were measured using spirometer in two situations: wearing EIT electrode belt and without electrode belt. The changes of the tidal volumes were analysed in order to conclude whether the electrode belt has any impact on the volumes.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Biomedical Engineering, Czech Technical University in Prague

Kladno, 27201, Czechia

About this study

Ten healthy, spontaneously breathing volunteers were in supine semi-sitting position and their tidal volume was measured for 15 min using spirometer Ergostick (Geratherm) twice: with electrode belt placed around the subjcest thorax in the level of 4th to 6th intercostal space in the parasternal line, and then without the electrode belt. The subjects were breathing for approx. 15 min sponatenously with deep, forced breathing in the last minute.

The stiff silicone electrode belt used for lung monitoring with electrical impedance tomography system PulmoVista 500 (Dräger Medical) is being placed tightly around the subjects chest in order to monitor distribution of the ventilation. The aim of the study is to analyse the differences in tidal volumes of the spontaneously breathing subject with and without the electrode belt.

Since the electrode belt is relatively stiff and the manufacturer recommends putting the belt on tightly, there is a possibility that it affects the breathing effort of the spontaneously breathing patients, which could possibly lead to lower tidal volumes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy volunteers

Exclusion criteria

  • morbid obesity
  • Tiffeneau index lower than 80 %
  • wounded skin in the electrode belt location

Treatment and study plan

EIT electrode belt, spirometry

Device

Placing electrode belt for EIT monitoring and measuring tidal volume with spirometer

Primary outcomes

  1. Changes in tidal volumes

    Time frame: 15 minutes

    Analysing the changes of tidal volumes caused by the presence of electrode belt

Sponsors and collaborators

Lead sponsor

Czech Technical University in Prague

Other

Registry information

Official study title

Effect of Electrode Belt Used for Lung Monitoring With Electrical Impedance Tomography on Tidal Volume of Healthy Volunteers

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 17, 2024
Registry last updated
May 20, 2024

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.