Spirometry Using Electrical Impedance Tomography

Realization of Spirometry Measurement Using Electrical Impedance Tomography (EIT)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03746795

Acronym

EIT

Enrollment

Registered

2018-11-20

Start date

2017-10-27

Completion date

2019-03-08

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

electrical impedance tomography, spirometric examination, bioimpedance, FVC, FEV1, Tiffeneau index

Brief summary

The main aim of this study is to test spirometry measurements using EIT with a calibration using tidal volume obtained from the simultaneous standard spirometry measurement. Another goal is to compare, based on the calibration, the spirometry parameters obtained from separate measurements using EIT and the standard spirometry using a pneumotachograph. All spirometry measurements will be conducted in accordance with the latest available standards of the American Thoracic Society (ATS) and European Respiratory Society (ERS) from the year 2005, including their emendation from 2017.

Detailed description

Adding the pneumotachograph and antibacterial filter to the respiratory system can lead to increased dead space, flow resistance, and change the respiratory pattern. All of these negative features and reduced patient co-operation affect the measured results and their interpretation. The aim of this study is to test spirometry measurement using EIT and evaluate such spirometry parameters as forced vital capacity (FVC), forced expiratory volume exhaled in the first second of a forced expiration (FEV1) and ratio of FEV1/FVC called Tiffeneau index (TI) based on recalculation using the calibration constant. The study will be conducted using Ergostik (Geratherm, Germany) spirometer and EIT system Pulmovista 500 (Dräger, Germany).

Interventions

DEVICESpirometric examinations realized using the EIT

Spirometric examinations will be realized using the EIT alone.

DEVICESimultaneous measurement by spirometer and EIT

Spirometric examinations will be realized using the simultaneous measurement by spirometer and EIT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

During the experiment, six measurements will be performed for each examined individual to calculate the spirometric parameters of FVC, FEV1 and Tiffenea's index (TI) FEV1/FVC. Spirometry measurements will be performed in a randomized order: two standard spirometric examinations, two spirometric examinations using EIT and two simultaneous measurements using both methods. Each subject will undergo all six measurements.

Eligibility

Sex/Gender

ALL

Age

18 Years to 28 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy males and females \> 18 years old * Signed informed consent has been obtained

Exclusion criteria

* Pregnancy * Cardiac pacemakers * Electrically active implant * Critical illness * Intrathoracic metal implants * Value of body mass index (BMI)\>50

Design outcomes

Primary

Measure	Time frame	Description
FEV1	through study completion, an average of 1 year	forced expiratory volume exhaled in the first second of a forced expiration (L)
TI	through study completion, an average of 1 year	ratio of FEV1/FVC called Tiffeneau index (-)
FVC	through study completion, an average of 1 year	forced vital capacity (L)

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026