Spirometry Using Electrical Impedance Tomography

Healthy Clinical Trial

— EIT  

Official title:

Realization of Spirometry Measurement Using Electrical Impedance Tomography (EIT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03746795
• Other study ID #: EITspiro
• Status: Completed
• Phase: N/A
• Start date: October 27, 2017
• Est. completion date: March 8, 2019

Study information

• Verified date: November 2018
• Source: Czech Technical University in Prague
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 8, 2019
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 28 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Spirometric examinations realized using the EIT
Spirometric examinations will be realized using the EIT alone.
• Simultaneous measurement by spirometer and EIT
Spirometric examinations will be realized using the simultaneous measurement by spirometer and EIT

Locations

Country	Name	City	State
Czechia	Department of Biomedical Technology Faculty of Biomedical Engineering Czech Technical University in Prague	Kladno	Czech Republic

Sponsors (1)

Lead Sponsor	Collaborator
Czech Technical University in Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (4)

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. — View Citation

Ngo C, Leonhardt S, Zhang T, Lüken 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. — View Citation

Vogt B, Löhr 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. — View 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. — View Citation

Outcome

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