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

NCT ID: NCT06419790

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2017-04-30

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.

Conditions

EIT Electrode Belt Stiffness; Tidal Volume Changes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Healthy volunteers

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.

Group Type: EXPERIMENTAL

EIT electrode belt, spirometry

Intervention Type: DEVICE

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

Interventions

EIT electrode belt, spirometry

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• healthy volunteers

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Czech Technical University in Prague

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristýna Koldová, Ph.D.

Role: STUDY_DIRECTOR

Faculty of Biomedical Engineering, Czech Technical University in Prague

Locations

Faculty of Biomedical Engineering, Czech Technical University in Prague

Kladno, , Czechia

Countries

Czechia

Other Identifiers

C3/017

Identifier Type: -

Identifier Source: org_study_id