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Accuracy of 3D Electrical Impedance Tomography for Assessing Lung Ventilation

2026年8月4日 更新者:Shanghai Zhongshan Hospital

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.

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.

研究概览

研究类型

观察性的

注册 (估计的)

50

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

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.

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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.
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.
其他名称:
  • 3D-EIT
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.
其他名称:
  • 4D-CT

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Deming and Passing-Bablok Regression Slopes and Intercepts Comparing Regional Ventilation Fraction Measured by 3D-EIT and 4D-CT
大体时间: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.
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.

次要结果测量

结果测量
措施说明
大体时间
Pearson Correlation Coefficient Between Regional Ventilation Fraction Measurements Obtained by 3D-EIT and 4D-CT
大体时间:Periprocedural, during the synchronous 3D-EIT and 4D-CT acquisition at the study visit
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.
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
大体时间:Periprocedural, during the synchronous 3D-EIT and 4D-CT acquisition at the study visit
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.
Periprocedural, during the synchronous 3D-EIT and 4D-CT acquisition at the study visit

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年7月1日

研究注册日期

首次提交

2026年7月30日

首先提交符合 QC 标准的

2026年8月4日

首次发布 (实际的)

2026年8月10日

研究记录更新

最后更新发布 (实际的)

2026年8月10日

上次提交的符合 QC 标准的更新

2026年8月4日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • B2026-447

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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