Spirometry Using Electrical Impedance Tomography

Study Overview
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Brief Summary
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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
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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).

Official Title
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Realization of Spirometry Measurement Using Electrical Impedance Tomography (EIT)

Conditions
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Healthy

Intervention / Treatment
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* Device: Spirometric examinations realized using the EIT
* Device: Simultaneous measurement by spirometer and EIT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 28 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard spirometry<br>Standard spirometry measurement with a pneumotachograph alone. | |
| Experimental: EIT alone<br>Spirometric examinations realized using the EIT | Device: Spirometric examinations realized using the EIT<br>* Spirometric examinations will be realized using the EIT alone.<br>|
| Experimental: Simultaneous standard spirometry and EIT<br>Simultaneous measurement by spirometer and EIT | Device: Simultaneous measurement by spirometer and EIT<br>* Spirometric examinations will be realized using the simultaneous measurement by spirometer and EIT<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electrical impedance tomography, spirometric examination, bioimpedance, FEV1, Tiffeneau index, FVC