Viewing Study NCT06419790



Ignite Creation Date: 2024-05-19 @ 5:33 PM
Last Modification Date: 2024-10-26 @ 3:30 PM
Study NCT ID: NCT06419790
Status: COMPLETED
Last Update Posted: 2024-05-20
First Post: 2024-05-14

Brief Title: Effect of Electrode Belt Used for Lung Monitoring With EIT on Tidal Volume
Sponsor: Czech Technical University in Prague
Organization: Czech Technical University in Prague

Study Overview

Official Title: Effect of Electrode Belt Used for Lung Monitoring With Electrical Impedance Tomography on Tidal Volume of Healthy Volunteers
Status: COMPLETED
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None