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临床试验/NCT07489950
NCT07489950已完成不适用

Non-apnea Saline-contrast EIT for Lung Perfusion Imaging in Spontaneously Breathing Patients: A Prospective Cross-over Study

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年1月10日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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