Lung DiseasesNCT07356076
The Use of Electrical Impedance Tomography (EIT) in Pulmonary Diseases
An observational study of Lung Diseases, run by University Hospital Olomouc at 1 site in Czechia.
Trial summary
The study titled "The Use of Electrical Impedance Tomography (EIT) in Pulmonary Diseases" investigates the impact of using EIT as a non-invasive method to monitor the distribution of pulmonary ventilation and its relationship to standard spirometry in patients with various lung diseases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Diseases
- How many people
- 400 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of the Department of Pulmonary Diseases and Tuberculosis, University hospital Olomouc, and healthy controls.
Who may be able to join
- Adults aged 18 years and older
- Individuals diagnosed with any of the following lung diseases, as these are the primary focus of the study: Chronic obstructive pulmonary disease, Asthma, Pulmonary fibrosis, Pneumonia, Patients with a history of COVID-19 infection showing residual pulmonary findings.
- Additionally, healthy subjects will be enrolled to obtain normal standard values (with normal physical examination and no respiratory symptoms, BMI 18-36 - cause EIT performance can be BMI dependent, Non-smokers or ex-smokers abstinent ≥12 months)
- Ability to perform spirometry while seated, except for possible participants who are specifically part of a subgroup analysis where inability to perform spirometry is the condition which is studied.
- Signing of an informed consent that has been approved by the ethics committee
Who cannot join
- Patients under 18 years of age
- Severe cardiovascular disease
- Pregnancy
- Inability to express consent
- Acute respiratory infection: Except for those recovering from pneumonia or COVID-19 within the study focus, participants with current respiratory infections will be excluded to avoid confounding effects on lung function tests
- Inability to perform spirometry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Department of Pulmonary Diseases and Tuberculosis, University hospital Olomouc
Olomouc, 77900
Samuel Genzor, Assoc. prof., MD, Ph.D., +420 588 443557, samuel.genzor@fnol.cz
Jan Mizera, MD
About this study
The study titled "The Use of Electrical Impedance Tomography (EIT) in Pulmonary Diseases" investigates the impact of using EIT as a non-invasive method to monitor the distribution of pulmonary ventilation and its relationship to standard spirometry in patients with various lung diseases. The main aim of this study is to investigate new approaches to the assessment of lung status and diagnosis of lung diseases.
Unlike spirometry, which has long been a well-known and important diagnostic tool in pulmonary medicine, and which provides valuable information about the volume and flow of inspired and expired air, EIT provides spatial information about the distribution of ventilation in real time and without the need for active patient cooperation. Research and practice have shown that spirometry is problematic in specific groups of patients, such as patients with tracheostomy or facial palsy. The technology should also enable detection of the disease in its early stages, when treatment is most effective.
Read more
300 participants in the experimental group and 100 participants in the control group will receive spirometry and electrical impedance tomography independent examination.
The primary endpoint of the study is to investigate the potential of EIT in respiratory medicine, specifically identifying the relationship between EIT and traditional spirometry. This effort is motivated by the need for novel noninvasive methods for the diagnosis and monitoring of respiratory diseases, especially in patients unable to undergo conventional spirometry, or in case of interventions requiring real-time feedback. The purpose of the research project in relation to these objectives is to bring new possibilities in the field of diagnosis and monitoring of lung diseases through EIT, which could lead to significant improvements in patient care.
Demographic and anthropometric data, including age, sex, body height, body weight, body mass index (BMI), chest circumference, and smoking history will be collected in all participants. These parameters will be used as covariates in the analysis to assess their impact on EIT-derived indicators and to improve normalization of EIT signals.
Additionally, the study aims to develop and validate a machine learning model, particularly a deep neural network, capable of predicting standard spirometric parameters (e.g., FEV1, FVC, PEF) based solely on EIT signals. This could allow for an accurate assessment of dynamic pulmonary volumes in cooperating patients who are unable to undergo conventional spirometry (e.g. patients with tracheostomy).
- Conditions
- Lung Diseases
- Keywords
- Electrical Impedance Tomography, Spirometry, Lung Diseases, Lung Assessment
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with lung diseases | Adults aged 18 years and older Individuals diagnosed with any of the following lung diseases, as these are the primary focus of the study: Chronic obstructive pulmonary disease, Asthma, Pulmonary fibrosis, Pneumonia, Patients with a history of COVID-19 infection showing residual pulmonary findings. Ability to perform spirometry while seated, except for possible participants who are specifically part of a subgroup analysis where inability to perform spirometry is the condition which is studied. Signing of an informed consent that has been approved by the ethics committee | |
| Healthy controls | Adults aged 18 years and older Healthy subjects will be enrolled to obtain normal standard values (with normal physical examination and no respiratory symptoms, BMI 18-31 - cause EIT performance can be BMI dependent, Non-smokers or ex-smokers abstinent ≥12 months) Ability to perform spirometry while seated, except for possible participants who are specifically part of a subgroup analysis where inability to perform spirometry is the condition which is studied. Signing of an informed consent that has been approved by the ethics committee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between EIT-derived FEV1 and spirometry-derived FEV1
Comparison of forced expiratory volume in 1 second predicted from EIT using a trained neural network with direct spirometry measurement.
Metric: Mean Absolute Error (MAE), Bland-Altman limits of agreement, Pearson correlation coefficient (r)
Measured: At baseline visit (single measurement)
Secondary outcomes (9)
Forced Expiratory Volume in One Second (FEV1)
FEV1 represents the volume of air that can be forcibly exhaled in the first second of a forced exhalation Measurements will be performed using calibrated spirometry. FEV1 is a standard measure of pulmonary function.
Unit of Measure: Liters
Measured: At baseline visit (single measurement)
Forced vital capacity (FVC)
FVC represents the largest amount of air that can be forcefully exhaled from maximum inspiration.
Unit of Measure: Liters
Measured: At baseline visit (single measurement)
Peak Expiratory Flow (PEF)
PEF represents the maximum flow achieved during forceful exhalation from maximum inspiration and is a reliable indicator of ventilation adequacy as well as airflow obstruction.
Unit of Measure: Liters/minute
Measured: At baseline visit (single measurement)
Estimated Lung Age (ELA)
ELA is a calculation that estimates the age of a person's lungs based on their lung function, particurarly FEV1 (forced expiratory volume in one second), compared to normal lung function for their chronological age. Secondary objectives include comparison of regional ventilation patterns from EIT with spirometric flow-volume loop abnormalities, assessment of EIT-based estimated lung age, and determination of EIT's ability to track treatment response over time.
Measured: At baseline visit (single measurement)
Forced Expiratory Volume in Three Seconds (FEV3)
FEV3 represents the volume of air that can be exhaled during the first three seconds of forceful exhalation after maximum inspiration.
Unit of Measure: Liters
Measured: At baseline visit (single measurement)
Forced Expiratory Volume in Six Seconds (FEV6)
FEV6 represents the volume of air that can be exhaled during the first six seconds of forceful exhalation after maximum inspiration
Unit of Measure: Liters
Measured: At baseline visit (single measurement
FEV1/FVC ratio
FEV1/FVC is the ratio of forced expiratory volume in one second to forced vital capacity.
Unit of Measure: Percentage
Measured: At baseline visit (single measurement
Forced Expiratory Flow at 50 % of FVC (FEF50)
FEF50 is the flow rate at the 50% point of the total volume (FVC) exhaled.
Unit of Measure: Liters
Measured: At baseline visit (single measurement
Forced Expiratory Flow at 75 % of FVC (FEF75)
FEF75 is the flow rate at the 75% point of the total volume exhaled.
Unit of Measure: Liters
Measured: At baseline visit (single measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Nov 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Collaborators
- Brno University of Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356076
- Sponsor's protocol ID
- OP JAK ITI VZ 3
- Other IDs
- CZ.02.01.01/00/23_021/0008829
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Electrical Impedance Tomography (EIT) in Pulmonary Diseases
- ClinicalTrials.gov ID
- NCT07356076
- Acronym / sponsor ID
- OP JAK ITI VZ 3
- Conditions
- Lung Diseases
- Keywords
- Electrical Impedance Tomography, Spirometry, Lung Diseases, Lung Assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Collaborators
- Brno University of Technology
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Jan 2026 (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 study titled "The Use of Electrical Impedance Tomography (EIT) in Pulmonary Diseases" investigates the impact of using EIT as a non-invasive method to monitor the distribution of pulmonary ventilation and its relationship to standard spirometry in patients with various lung diseases. The main aim of this study is to investigate new approaches to the assessment of lung status and diagnosis of lung diseases.
Unlike spirometry, which has long been a well-known and important diagnostic tool in pulmonary medicine, and which provides valuable information about the volume and flow of inspired and expired air, EIT provides spatial information about the distribution of ventilation in real time and without the need for active patient cooperation. Research and practice have shown that spirometry is problematic in specific groups of patients, such as patients with tracheostomy or facial palsy. The technology should also enable detection of the disease in its early stages, when treatment is most effective.
300 participants in the experimental group and 100 participants in the control group will receive spirometry and electrical impedance tomography independent examination.
The primary endpoint of the study is to investigate the potential of EIT in respiratory medicine, specifically identifying the relationship between EIT and traditional spirometry. This effort is motivated by the need for novel noninvasive methods for the diagnosis and monitoring of respiratory diseases, especially in patients unable to undergo conventional spirometry, or in case of interventions requiring real-time feedback. The purpose of the research project in relation to these objectives is to bring new possibilities in the field of diagnosis and monitoring of lung diseases through EIT, which could lead to significant improvements in patient care.
Demographic and anthropometric data, including age, sex, body height, body weight, body mass index (BMI), chest circumference, and smoking history will be collected in all participants. These parameters will be used as covariates in the analysis to assess their impact on EIT-derived indicators and to improve normalization of EIT signals.
Additionally, the study aims to develop and validate a machine learning model, particularly a deep neural network, capable of predicting standard spirometric parameters (e.g., FEV1, FVC, PEF) based solely on EIT signals. This could allow for an accurate assessment of dynamic pulmonary volumes in cooperating patients who are unable to undergo conventional spirometry (e.g. patients with tracheostomy).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with lung diseases | – | –Adults aged 18 years and older Individuals diagnosed with any of the following lung diseases, as these are the primary focus of the study: Chronic obstructive pulmonary disease, Asthma, Pulmonary fibrosis, Pneumonia, Patients with a history of COVID-19 infection showing residual pulmonary findings. Ability to perform spirometry while seated, except for possible participants who are specifically part of a subgroup analysis where inability to perform spirometry is the condition which is studied. Signing of an informed consent that has been approved by the ethics committee |
| Healthy controls | – | –Adults aged 18 years and older Healthy subjects will be enrolled to obtain normal standard values (with normal physical examination and no respiratory symptoms, BMI 18-31 - cause EIT performance can be BMI dependent, Non-smokers or ex-smokers abstinent ≥12 months) Ability to perform spirometry while seated, except for possible participants who are specifically part of a subgroup analysis where inability to perform spirometry is the condition which is studied. Signing of an informed consent that has been approved by the ethics committee |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the Department of Pulmonary Diseases and Tuberculosis, University hospital Olomouc, and healthy controls.
Key inclusion criteria (5 listed)
- Adults aged 18 years and older
- Individuals diagnosed with any of the following lung diseases, as these are the primary focus of the study: Chronic obstructive pulmonary disease, Asthma, Pulmonary fibrosis, Pneumonia, Patients with a history of COVID-19 infection showing residual pulmonary findings.
- Additionally, healthy subjects will be enrolled to obtain normal standard values (with normal physical examination and no respiratory symptoms, BMI 18-36 - cause EIT performance can be BMI dependent, Non-smokers or ex-smokers abstinent ≥12 months)
- Ability to perform spirometry while seated, except for possible participants who are specifically part of a subgroup analysis where inability to perform spirometry is the condition which is studied.
- Signing of an informed consent that has been approved by the ethics committee
Key exclusion criteria (6 listed)
- Patients under 18 years of age
- Severe cardiovascular disease
- Pregnancy
- Inability to express consent
- Acute respiratory infection: Except for those recovering from pneumonia or COVID-19 within the study focus, participants with current respiratory infections will be excluded to avoid confounding effects on lung function tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement between EIT-derived FEV1 and spirometry-derived FEV1
Time frame: At baseline visit (single measurement)
Comparison of forced expiratory volume in 1 second predicted from EIT using a trained neural network with direct spirometry measurement. Metric: Mean Absolute Error (MAE), Bland-Altman limits of agreement, Pearson correlation coefficient (r)
9 secondary outcomes
Forced Expiratory Volume in One Second (FEV1)
Time frame: At baseline visit (single measurement)
Forced vital capacity (FVC)
Time frame: At baseline visit (single measurement)
Peak Expiratory Flow (PEF)
Time frame: At baseline visit (single measurement)
Estimated Lung Age (ELA)
Time frame: At baseline visit (single measurement)
Forced Expiratory Volume in Three Seconds (FEV3)
Time frame: At baseline visit (single measurement)
Forced Expiratory Volume in Six Seconds (FEV6)
Time frame: At baseline visit (single measurement
FEV1/FVC ratio
Time frame: At baseline visit (single measurement
Forced Expiratory Flow at 50 % of FVC (FEF50)
Time frame: At baseline visit (single measurement
Forced Expiratory Flow at 75 % of FVC (FEF75)
Time frame: At baseline visit (single measurement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Department of Pulmonary Diseases and Tuberculosis, University hospital Olomouc
Olomouc, Czechia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, run by University Hospital Olomouc 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 5 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: looking for participants now, as of the sponsor's last update on 27 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between EIT-derived FEV1 and spirometry-derived FEV1 (time frame: At baseline visit (single measurement)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2026.