Clinical trial NCT03746795: Spirometry Using Electrical Impedance Tomography
Official title: Realization of Spirometry Measurement Using Electrical Impedance Tomography (EIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: electrical impedance tomography
spirometric examination
bioimpedance
FVC
FEV1
Tiffeneau index
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: FVC
timeFrame: through study completion, an average of 1 year
measure: FEV1
timeFrame: through study completion, an average of 1 year
measure: TI
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kladno
country: Czechia
facility: Department of Biomedical Technology Faculty of Biomedical Engineering Czech Technical University in Prague
state: Czech Republic
Study officials:
affiliation: Czech Technical University in Prague, FBMI
name: Karel Roubík, prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ngo C, Leonhardt S, Zhang T, Luken M, Misgeld B, Vollmer T, Tenbrock K, Lehmann S. Linearity of electrical impedance tomography during maximum effort breathing and forced expiration maneuvers. Physiol Meas. 2017 Jan;38(1):77-86. doi: 10.1088/1361-6579/38/1/77. Epub 2016 Dec 22.
citation: Vogt B, Lohr S, Zhao Z, Falkenberg C, Ankermann T, Weiler N, Frerichs I. Regional lung function testing in children using electrical impedance tomography. Pediatr Pulmonol. 2018 Mar;53(3):293-301. doi: 10.1002/ppul.23912. Epub 2017 Nov 14.
citation: Lehmann S, Leonhardt S, Ngo C, Bergmann L, Ayed I, Schrading S, Tenbrock K. Global and regional lung function in cystic fibrosis measured by electrical impedance tomography. Pediatr Pulmonol. 2016 Nov;51(11):1191-1199. doi: 10.1002/ppul.23444. Epub 2016 Apr 29.
citation: Vogt B, Zhao Z, Zabel P, Weiler N, Frerichs I. Regional lung response to bronchodilator reversibility testing determined by electrical impedance tomography in chronic obstructive pulmonary disease. Am J Physiol Lung Cell Mol Physiol. 2016 Jul 1;311(1):L8-L19. doi: 10.1152/ajplung.00463.2015. Epub 2016 May 17.