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

Not Applicable

Completed

• Conditions: EIT Electrode Belt Stiffness; Tidal Volume Changes
• Interventions: Device: EIT electrode belt, spirometry

• Registration Number: NCT06419790
• Lead Sponsor: Czech Technical University in Prague

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-10-01
• Primary Completion: 2017-04-30
• Study Completion: 2017-04-30
• Status Verified: 2024-05
• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-17
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• healthy volunteers

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	EIT electrode belt, spirometry	Data were obtained at two phases at supine semi-sitting position during 15 min sponatenous breathing and 1 min forced breathing. Subjects were breathing through spirometric probe first without electrode belt, and second with electrode belt placed tightly around the thorax as recommened by the manufacturer.

Primary Outcome Measures

Name	Time	Method
Changes in tidal volumes	15 minutes	Analysing the changes of tidal volumes caused by the presence of electrode belt

Trial Locations

Locations (1)

Faculty of Biomedical Engineering, Czech Technical University in Prague; 🇨🇿 Kladno, Czechia