HealthyEITNCT03746795
Spirometry Using Electrical Impedance Tomography
A study testing Spirometric examinations realized using the EIT and Simultaneous measurement by spirometer and EIT in people with Healthy, run by Czech Technical University in Prague at 1 site in Czechia.
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… Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Spirometric examinations realized using the EIT and Simultaneous measurement by spirometer and EIT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCzechia
- Study dates
- 27 Oct 2017to 8 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females > 18 years old
- Signed informed consent has been obtained
Who cannot join
- Pregnancy
- Cardiac pacemakers
- Electrically active implant
- Critical illness
- Intrathoracic metal implants
- Value of body mass index (BMI)>50
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Biomedical Technology Faculty of Biomedical Engineering Czech Technical University in Prague
Kladno, Czech Republic, 272 01
About this study
Official title: Realization of Spirometry Measurement Using Electrical Impedance Tomography (EIT)
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.
Read the 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).
- Conditions
- Healthy
- Being tested
- Spirometric examinations realized using the EIT, Simultaneous measurement by spirometer and EIT
- Keywords
- electrical impedance tomography, spirometric examination, bioimpedance, FVC, FEV1, Tiffeneau index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirometric examinations realized using the EITDevice
Spirometric examinations will be realized using the EIT alone.
Simultaneous measurement by spirometer and EITDevice
Spirometric examinations will be realized using the simultaneous measurement by spirometer and EIT
| Study group | Role | What they receive |
|---|---|---|
| Standard spirometry | No intervention | Standard spirometry measurement with a pneumotachograph alone. |
| EIT alone | Experimental | Spirometric examinations realized using the EIT Receives: Device: Spirometric examinations realized using the EIT |
| Simultaneous standard spirometry and EIT | Experimental | Simultaneous measurement by spirometer and EIT Receives: Device: Simultaneous measurement by spirometer and EIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
FVC
forced vital capacity (L)
Measured: through study completion, an average of 1 year
FEV1
forced expiratory volume exhaled in the first second of a forced expiration (L)
Measured: through study completion, an average of 1 year
TI
ratio of FEV1/FVC called Tiffeneau index (-)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start27 Oct 2017
- Primary completion30 Jan 2018
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karel Roubík, prof., Principal investigator, Czech Technical University in Prague, FBMI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746795
- Sponsor's protocol ID
- EITspiro
- Acronym
- EIT
- Status last verified
- Nov 2018
- First submitted
- 13 Nov 2018
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: EIT anonymous images and corresponding spirometry data.
Publications
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.
PubMed 28004642Vogt 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.
PubMed 29136345Lehmann 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.
PubMed 27127915Vogt 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.
PubMed 27190067
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Realization of Spirometry Measurement Using Electrical Impedance Tomography (EIT)
- ClinicalTrials.gov ID
- NCT03746795
- Acronym / sponsor ID
- EIT / EITspiro
- Conditions
- Healthy
- Keywords
- electrical impedance tomography, spirometric examination, bioimpedance, FVC, FEV1, Tiffeneau index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard spirometry | No intervention | –Standard spirometry measurement with a pneumotachograph alone. |
| EIT alone | Experimental | Device: Spirometric examinations realized using the EITSpirometric examinations realized using the EIT |
| Simultaneous standard spirometry and EIT | Experimental | Device: Simultaneous measurement by spirometer and EITSimultaneous measurement by spirometer and EIT |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males and females > 18 years old
- Signed informed consent has been obtained
Key exclusion criteria (6 listed)
- Pregnancy
- Cardiac pacemakers
- Electrically active implant
- Critical illness
- Intrathoracic metal implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spirometric examinations realized using the EITSpirometric examinations will be realized using the EIT alone. | Device | EIT alone |
| Simultaneous measurement by spirometer and EITSpirometric examinations will be realized using the simultaneous measurement by spirometer and EIT | Device | Simultaneous standard spirometry and EIT |
Primary outcome
FVC
Time frame: through study completion, an average of 1 year
forced vital capacity (L)
FEV1
Time frame: through study completion, an average of 1 year
forced expiratory volume exhaled in the first second of a forced expiration (L)
TI
Time frame: through study completion, an average of 1 year
ratio of FEV1/FVC called Tiffeneau index (-)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Background: PubMed 28004642Ngo 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.
- Background: PubMed 29136345Vogt 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.
- Background: PubMed 27127915Lehmann 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.
- Background: PubMed 27190067Vogt 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.
- Individual participant dataSharing planned: Undecided. EIT anonymous images and corresponding spirometry data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karel Roubík, prof. principal investigator
Czech Technical University in Prague, FBMI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirometric examinations realized using the EIT and Simultaneous measurement by spirometer and EIT in people with Healthy, run by Czech Technical University in Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FVC (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03746795, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.