Accuracy of Three-Dimensional Electrical Impedance Tomography for Assessing Dynamic Regional Lung Ventilation Validated by Four-Dimensional CT: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Deming and Passing-Bablok Regression Slopes and Intercepts Comparing Regional Ventilation Fraction Measured by 3D-EIT and 4D-CT
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Three-Dimensional Electrical Impedance Tomography (Device)
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.
干预措施: Dynamic Chest Computed Tomography (Diagnostic Test)
结局指标
主要结局
Deming and Passing-Bablok Regression Slopes and Intercepts Comparing Regional Ventilation Fraction Measured by 3D-EIT and 4D-CT
时间窗: 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.
次要结局
- Pearson Correlation Coefficient Between Regional Ventilation Fraction Measurements Obtained by 3D-EIT and 4D-CT(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(Periprocedural, during the synchronous 3D-EIT and 4D-CT acquisition at the study visit)