Non-apnea Saline-contrast EIT for Lung Perfusion Imaging in Spontaneously Breathing Patients: A Prospective Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Spearman correlation coefficient (r)
研究概览
简要总结
Title: Validating the Accuracy of Lung Blood Flow Monitoring Without Breath-Holding Under Spontaneous Breathing Support
Purpose: The purpose of this study is to evaluate the accuracy of a new Electrical Impedance Tomography (EIT) technique that measures lung blood flow (perfusion) without requiring patients to hold their breath. We aim to determine if this "non-apnea" method provides results consistent with the current clinical gold standard (the "pause" method).
Background: EIT is a non-invasive bedside tool used to monitor lung function. The traditional method for measuring lung blood flow requires patients to hold their breath for 5-8 seconds during a saline injection to avoid interference from breathing. However, many patients-especially those using a nasal cannula, high-flow nasal oxygen (HFNO), or pressure support ventilation (PSV)-must maintain continuous spontaneous breathing and find it difficult or unsafe to hold their breath. If a "non-apnea" method is proven accurate, it will make monitoring safer and easier for these patients.
What the Study Involves: The study includes stable adult patients who are breathing spontaneously. Each patient undergoes two measurements in a randomized order:
Standard Reference (Pause Method): Measurement taken during a brief, guided breath-hold.
Test Method (Non-Apnea Method): Measurement taken during normal, uninterrupted breathing while receiving respiratory support (Nasal Cannula, HFNO, or PSV).
Expected Significance: By comparing the lung images and ventilation/perfusion (V/Q) data from both methods, this study seeks to validate the reliability and precision of the non-apnea approach. This would allow clinicians to assess lung health in spontaneously breathing patients without interrupting their natural breathing rhythm.
详细描述
Study Design
This is a prospective, randomized, cross-over, within-subject validation study of accuracy.
The primary objective is to quantitatively assess the agreement between lung perfusion data acquired during uninterrupted spontaneous breathing (non-apnea method) and data acquired during the standard end-expiratory pause (pause method).
Participant Population and Respiratory Support
The study enrolls stable adult patients with active spontaneous breathing efforts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 years.
- •Requiring respiratory support including Nasal Cannula, High-Flow Nasal Oxygen (HFNO), or Pressure Support Ventilation (PSV).
- •Hemodynamically stable.
- •Able to tolerate a brief respiratory pause (for the reference group).
- •Signed informed consent.
排除标准
- •Pregnancy or breastfeeding.
- •Contraindications to electrical impedance tomography (e.g., cardiac pacemaker, skin integrity issues on the chest).
- •Severe circulatory failure or cardiogenic shock.
- •Known allergy to hypertonic saline.
结局指标
主要结局
Spearman correlation coefficient (r)
时间窗: Within 30 minutes
The Spearman correlation coefficient will be calculated to assess the voxel-by-voxel agreement of lung perfusion maps generated by the non-apnea algorithm compared to the reference standard (breath-hold method).
次要结局
未报告次要终点
