Non-invasive Central Venous Pressure Estimation in Cardiac Intensive Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Mean venous pressure to assess accuracy
研究概览
简要总结
The non-invasive central venous pressure estimation in adult cardiac intensive care units (CICU) patients study is a single-center, single-arm, investigator-blinded, interventional, intra-participant comparative, feasibility study. This study aims to assess the safety and preliminary accuracy of external jugular venous occlusion pressure measured non-invasively with the venous occlusion pressure monitoring device (CPMX2) in adult CICU patients. As a feasibility study, the primary goal is to gather preliminary data on the feasibility, safety, and effectiveness of the non-invasive CVP estimation method. Although single arm, the study will compare non-invasive CVP measurements with standard invasive CVP measurements taken concurrently. This intra-participant comparative approach is essential to validate the correlation and reliability of the non-invasive method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Provision of signed and dated informed consent
- •Admitted to the CICU with invasive CVP/RA pressure monitoring placed by standard of care as determined by the treating team before enrollment
- •No more than moderate TR as assessed by echocardiogram
排除标准
- •Undergoing positive pressure ventilation (Bipap or invasive mechanical ventilation)
- •Non-visible external jugular vein bilaterally (by visual examination or with traditional ultrasound examination)
- •History of thrombosis in any of the following vessels bilaterally; external jugular vein, internal jugular vein, brachiocephalic vein or superior vena cava
- •Skin lesions, vascular access sites or dressings covering neck and impeding access to the external jugular veins at the level of the muscle belly of the sternocleidomastoid muscle
研究组 & 干预措施
Adult CICU patients- CPMX2
Adult participants admitted to the CICU will have external jugular venous occlusion pressure measured twice non-invasively with the venous occlusion pressure monitoring device (CPMX2) and twice using standard of care invasive central venous pressure (CVP) measurements. All measurements will be taken concurrently. This is a with-in participant design.
干预措施: CPMX2 (Device)
结局指标
主要结局
Mean venous pressure to assess accuracy
时间窗: Day 1
Mean CPMX2 external jugular occlusion pressure will be compared to invasive CVP measurement in mmHg
Number of adverse events to assess safety
时间窗: Day 1
Safety measured by number of adverse events related to or potentially related to the study device and device deficiencies reported during study
Number of device deficiencies to assess safety
时间窗: Day 1
Safety measured by number of device deficiencies reported during study
次要结局
- Mean Point-of-care ultrasound (POCUS)-derived pressure measurements(Day 1)