Pulmonary VentilationNCT07756086
Accuracy of 3D Electrical Impedance Tomography for Assessing Lung Ventilation
An observational study of Pulmonary Ventilation, run by Shanghai Zhongshan Hospital.
Trial summary
This prospective observational study will evaluate how accurately three-dimensional electrical impedance tomography (3D-EIT) measures the distribution of air in the lungs during breathing when compared with four-dimensional computed tomography (4D-CT). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Ventilation
- What is being tested?
- Three-Dimensional Electrical Impedance Tomography and Dynamic Chest Computed Tomography
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Jul 2027
- 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: The study population will include adults aged 18 years or older recruited at the Department of Critical Care Medicine, Zhongshan Hospital, Fudan University. Participants will consist of healthy volunteers and intensive care unit patients for whom CT imaging is considered necessary based on the treating physician's clinical judgment. Eligible participants must be able to undergo simultaneous 4D-CT and 3D-EIT monitoring. This is a prospective, observational, single-center study. Participation will not alter the participant's routine clinical management, and the research-derived three-dimensional EIT reconstruction results will not be used directly to make clinical treatment decisions.
Who may be able to join
- Age 18 years or older.
- Healthy volunteers or patients in the intensive care unit for whom CT imaging is considered necessary based on the treating physician's clinical judgment.
- Able to cooperate with or undergo simultaneous 4D-CT and 3D-EIT monitoring.
- Able to provide written informed consent personally or through a legally authorized representative, as applicable.
Who cannot join
- Unable to tolerate or having a contraindication to 4D-CT examination, including pregnancy or severe respiratory distress.
- Extensive chest skin injury or infection, or any condition preventing placement of the EIT electrode belt.
- Body size or chest deformity that may substantially limit the quality of EIT or CT data, including chest circumference outside the compatible range of the EIT device.
- Presence of an implanted electronic device that may interfere with EIT signals, such as a cardiac pacemaker.
- Unable to complete simultaneous 4D-CT and 3D-EIT monitoring because of significant motion, persistent coughing, poor cooperation, or other technical or clinical reasons.
- Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Accuracy of Three-Dimensional Electrical Impedance Tomography for Assessing Dynamic Regional Lung Ventilation Validated by Four-Dimensional CT: A Prospective Observational Study
This prospective observational study will evaluate how accurately three-dimensional electrical impedance tomography (3D-EIT) measures the distribution of air in the lungs during breathing when compared with four-dimensional computed tomography (4D-CT).
3D-EIT is a noninvasive, radiation-free imaging method that measures changes in electrical impedance across the chest and can provide continuous information about regional lung ventilation. In this study, 4D-CT will be used as the reference method because it can provide detailed images of changes in the lungs throughout the breathing cycle.
Read more
Approximately 50 adults, including healthy volunteers and hospitalized patients who are able to undergo both examinations, will be enrolled at a single center. EIT and CT data will be collected at the same time during stable breathing. Researchers will compare the two methods to determine how closely their measurements of ventilation in different lung regions agree. The study will also explore whether EIT can detect changes in regional ventilation under different breathing conditions.
The study will not use the research EIT results to make clinical treatment decisions. The findings may support the future use of EIT as a noninvasive, radiation-free method for monitoring regional lung ventilation.
- Conditions
- Pulmonary Ventilation
- Being tested
- Three-Dimensional Electrical Impedance Tomography, Dynamic Chest Computed Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-Dimensional Electrical Impedance TomographyDevice
Also called 3D-EIT
Regional lung ventilation data will be collected using a chest electrical impedance tomography system (V200-S). Electrical impedance changes in the chest will be measured continuously and reconstructed to assess three-dimensional regional ventilation distribution. EIT data will be acquired synchronously with dynamic computed tomography data and will be used for research analysis only. The research EIT results will not directly guide clinical treatment decisions.
Dynamic Chest Computed TomographyDiagnostic test
Also called 4D-CT
Dynamic chest computed tomography data will be acquired using an X-ray computed tomography system (uCT 610 Sim) during one or more breathing cycles. The images will be reconstructed and analyzed to quantify changes in regional lung air volume and ventilation distribution. The 4D-CT measurements will serve as the reference method for comparison with 3D-EIT measurements.
| Study group | Role | What they receive |
|---|---|---|
| Paired 3D-EIT and 4D-CT Assessment Cohort | This single cohort will include approximately 50 adults, including healthy volunteers and hospitalized patients, who are able to undergo synchronous 3D-EIT and 4D-CT data acquisition. Regional lung ventilation measurements obtained by the two methods during the same breathing cycle will be compared for agreement and accuracy. Participants will not be assigned to different study groups, and the research EIT results will not be used to direct clinical treatment. Receives: Device: Three-Dimensional Electrical Impedance Tomography; Diagnostic Test: Dynamic Chest Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deming and Passing-Bablok Regression Slopes and Intercepts Comparing Regional Ventilation Fraction Measured by 3D-EIT and 4D-CT
For each participant, paired regional ventilation fraction measurements obtained by 3D-EIT and 4D-CT during the same synchronized respiratory cycle will be analyzed. Regional ventilation fraction will be expressed as the percentage of total ventilation within each predefined lung region. Prespecified regions may include the ventral and dorsal lung regions, dependent and nondependent regions, and the left and right lungs. Agreement between the two methods will be assessed using Deming regression and Passing-Bablok regression. Regression slopes, intercepts, and their 95% confidence intervals will be reported. A slope closer to 1 and an intercept closer to 0 indicate better agreement between the two methods.
Measured: Periprocedural, during synchronous 3D-EIT and 4D-CT acquisition at the study visit; one respiratory cycle is from the onset of one inspiration to the onset of the next.
Secondary outcomes (2)
Pearson Correlation Coefficient Between Regional Ventilation Fraction Measurements Obtained by 3D-EIT and 4D-CT
Paired regional ventilation fraction measurements obtained from spatially and temporally aligned 3D-EIT and 4D-CT ventilation data will be evaluated using the Pearson correlation coefficient. Regional ventilation fraction will be expressed as the percentage of total ventilation within each predefined lung region. Analyses will be performed for predefined regions, including the ventral and dorsal regions, left and right lungs, and dependent and nondependent regions, as applicable. Pearson correlation coefficients and their 95% confidence intervals will be reported.
Measured: Periprocedural, during the synchronous 3D-EIT and 4D-CT acquisition at the study visit
Mean Bias and 95% Limits of Agreement Between Regional Ventilation Fraction Measurements Obtained by 3D-EIT and 4D-CT
Agreement between paired regional ventilation fraction measurements obtained by 3D-EIT and 4D-CT will be evaluated using Bland-Altman analysis. Regional ventilation fraction will be expressed as the percentage of total ventilation within each predefined lung region. The mean difference between the two methods, corresponding 95% confidence interval, and the lower and upper 95% limits of agreement will be reported.
Measured: Periprocedural, during the synchronous 3D-EIT and 4D-CT acquisition at the study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary VentilationStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756086
- Sponsor's protocol ID
- B2026-447
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Three-Dimensional Electrical Impedance Tomography for Assessing Dynamic Regional Lung Ventilation Validated by Four-Dimensional CT: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07756086
- Acronym / sponsor ID
- B2026-447
- Conditions
- Pulmonary Ventilation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 10 Aug 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.
This prospective observational study will evaluate how accurately three-dimensional electrical impedance tomography (3D-EIT) measures the distribution of air in the lungs during breathing when compared with four-dimensional computed tomography (4D-CT).
3D-EIT is a noninvasive, radiation-free imaging method that measures changes in electrical impedance across the chest and can provide continuous information about regional lung ventilation. In this study, 4D-CT will be used as the reference method because it can provide detailed images of changes in the lungs throughout the breathing cycle.
Approximately 50 adults, including healthy volunteers and hospitalized patients who are able to undergo both examinations, will be enrolled at a single center. EIT and CT data will be collected at the same time during stable breathing. Researchers will compare the two methods to determine how closely their measurements of ventilation in different lung regions agree. The study will also explore whether EIT can detect changes in regional ventilation under different breathing conditions.
The study will not use the research EIT results to make clinical treatment decisions. The findings may support the future use of EIT as a noninvasive, radiation-free method for monitoring regional lung ventilation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paired 3D-EIT and 4D-CT Assessment Cohort | – | Device: Three-Dimensional Electrical Impedance Tomography, Diagnostic Test: Dynamic Chest Computed TomographyThis single cohort will include approximately 50 adults, including healthy volunteers and hospitalized patients, who are able to undergo synchronous 3D-EIT and 4D-CT data acquisition. Regional lung ventilation measurements obtained by the two methods during the same breathing cycle will be compared for agreement and accuracy. Participants will not be assigned to different study groups, and the research EIT results will not be used to direct clinical treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adults aged 18 years or older recruited at the Department of Critical Care Medicine, Zhongshan Hospital, Fudan University. Participants will consist of healthy volunteers and intensive care unit patients for whom CT imaging is considered necessary based on the treating physician's clinical judgment. Eligible participants must be able to undergo simultaneous 4D-CT and 3D-EIT monitoring. This is a prospective, observational, single-center study. Participation will not alter the participant's routine clinical management, and the research-derived three-dimensional EIT reconstruction results will not be used directly to make clinical treatment decisions.
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Healthy volunteers or patients in the intensive care unit for whom CT imaging is considered necessary based on the treating physician's clinical judgment.
- Able to cooperate with or undergo simultaneous 4D-CT and 3D-EIT monitoring.
- Able to provide written informed consent personally or through a legally authorized representative, as applicable.
Key exclusion criteria (6 listed)
- Unable to tolerate or having a contraindication to 4D-CT examination, including pregnancy or severe respiratory distress.
- Extensive chest skin injury or infection, or any condition preventing placement of the EIT electrode belt.
- Body size or chest deformity that may substantially limit the quality of EIT or CT data, including chest circumference outside the compatible range of the EIT device.
- Presence of an implanted electronic device that may interfere with EIT signals, such as a cardiac pacemaker.
- Unable to complete simultaneous 4D-CT and 3D-EIT monitoring because of significant motion, persistent coughing, poor cooperation, or other technical or clinical reasons.
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 |
|---|---|---|
| Three-Dimensional Electrical Impedance TomographyAlso: 3D-EITRegional lung ventilation data will be collected using a chest electrical impedance tomography system (V200-S). Electrical impedance changes in the chest will be measured continuously and reconstructed to assess three-dimensional regional ventilation distribution. EIT data will be acquired synchronously with dynamic computed tomography data and will be used for research analysis only. The research EIT results will not directly guide clinical treatment decisions. | Device | Paired 3D-EIT and 4D-CT Assessment Cohort |
| Dynamic Chest Computed TomographyAlso: 4D-CTDynamic chest computed tomography data will be acquired using an X-ray computed tomography system (uCT 610 Sim) during one or more breathing cycles. The images will be reconstructed and analyzed to quantify changes in regional lung air volume and ventilation distribution. The 4D-CT measurements will serve as the reference method for comparison with 3D-EIT measurements. | Diagnostic test | Paired 3D-EIT and 4D-CT Assessment Cohort |
Primary outcome
Deming and Passing-Bablok Regression Slopes and Intercepts Comparing Regional Ventilation Fraction Measured by 3D-EIT and 4D-CT
Time frame: Periprocedural, during synchronous 3D-EIT and 4D-CT acquisition at the study visit; one respiratory cycle is from the onset of one inspiration to the onset of the next.
For each participant, paired regional ventilation fraction measurements obtained by 3D-EIT and 4D-CT during the same synchronized respiratory cycle will be analyzed. Regional ventilation fraction will be expressed as the percentage of total ventilation within each predefined lung region. Prespecified regions may include the ventral and dorsal lung regions, dependent and nondependent regions, and the left and right lungs. Agreement between the two methods will be assessed using Deming regression and Passing-Bablok regression. Regression slopes, intercepts, and their 95% confidence intervals will be reported. A slope closer to 1 and an intercept closer to 0 indicate better agreement between the two methods.
2 secondary outcomes
Pearson Correlation Coefficient Between Regional Ventilation Fraction Measurements Obtained by 3D-EIT and 4D-CT
Time frame: Periprocedural, during the synchronous 3D-EIT and 4D-CT acquisition at the study visit
Mean Bias and 95% Limits of Agreement Between Regional Ventilation Fraction Measurements Obtained by 3D-EIT and 4D-CT
Time frame: Periprocedural, during the synchronous 3D-EIT and 4D-CT acquisition at the study visit
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 10 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Ventilation, run by Shanghai Zhongshan Hospital.
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 4 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: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Yuxian Wang (+86 021 6404 1990, wang.yuxian@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deming and Passing-Bablok Regression Slopes and Intercepts Comparing Regional Ventilation Fraction Measured by 3D-EIT and 4D-CT (time frame: Periprocedural, during synchronous 3D-EIT and 4D-CT acquisition at the study visit; one respiratory cycle is from the onset of one inspiration to the onset of the next.). 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 10 Aug 2026.