## Protocol Section
### Identification Module
**NCT ID:** NCT06419790

**Brief Title:** Effect of Electrode Belt Used for Lung Monitoring With EIT on Tidal Volume

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

#### Organization Study ID Info
**ID:** C3/017
#### Organization
**Class:** OTHER
**Full Name:** Czech Technical University in Prague
### Status Module
#### Completion Date
**Date:** 2017-04-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-04-30

**Type:** ACTUAL

#### Start Date
**Date:** 2016-10-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Czech Technical University in Prague

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- EIT Electrode Belt Stiffness

- Tidal Volume Changes

**Keywords:**

- electrode belt

- EIT

- spirometry

- tidal volume

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 10

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: EIT electrode belt, spirometry

**Label:** Healthy volunteers

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Healthy volunteers

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

**Name:** EIT electrode belt, spirometry

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Analysing the changes of tidal volumes caused by the presence of electrode belt

**Measure:** Changes in tidal volumes

**Time Frame:** 15 minutes

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

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

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kladno

**Country:** Czechia

**Facility:** Faculty of Biomedical Engineering, Czech Technical University in Prague

**Zip:** 27201

#### Overall Officials

**Official 1:**

**Affiliation:** Faculty of Biomedical Engineering, Czech Technical University in Prague

**Name:** Kristýna Koldová, Ph.D.

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
