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临床试验/NCT04179851
NCT04179851Unknown不适用

Comparison of Non-invasive to Invasive Assessment of Jugular Venous Pressure

Shaare Zedek Medical Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年2月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
central venous pressure (direct and indirect evaluation)

研究概览

简要总结

Assessment of the jugular venous pressure (JVP) is an important clinical sign and correlates with right atrial (RA) pressure. A patient with heart failure (HF) typically has an elevated JVP, but in cases of dehydration JVP may be low. Assessment of the JVP is key to the management of patients with fluid overload or needing diuretics. Currently the assessment of JVP is made by the physician by direct visualization of the neck veins. However this is inaccurate, may vary between investigators and depends largely on the patient's habitus. The JVP and RA pressures may also be directly measured by catheterization (a routine during right heart catheterization), but this is an invasive procedure that is seldom performed.

A thermal movie of the external jugular vein at a specific neck position may help to measure the JVP. In this study different modalities of JVP assessment (clinical assessment, thermal image and invasive measurement) are to be compared

Patients scheduled for right heart catheterization at the Shaare Zedek Medical Center for non-study related medical indications will be approached.

Non-invasive estimates of JVP will be performed independently prior to the right heart catheterization, during the waiting period (within 2 hours) prior to catheterization. These will include up to 2min of thermal camera recording (to be analysed offline) and a physician's JVP evaluation. The angle of the patient's upper body will be 30-60°, the rotation of the neck will be optimal for filming, and the neck area may be cooled to enhance the images. Blinding to the results will be confirmed by performance with separate investigators and separate data registration. Right heart catheterization will then be performed and RA pressure will be recorded, as well as pulmonary and wedge pressures. JVP measured by physician and thermal image will be matched with invasive catheterization (the gold standard) using Bland Altman plots and Spearmann correlation and comparison between methods will be performed.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients already scheduled for right heart catheterization for clinical indication

排除标准

  • Local scar wound or bruise in the right side of the neck.
  • Current upper torso central venous catheterization such as a PICC line or dialysis catheter.

结局指标

主要结局

central venous pressure (direct and indirect evaluation)

时间窗: up to 30 days for analysis of the thermal images, up to 24hours for the direct measurement

comparison of estimated venous pressure (in mmHg) to the direct measurement during right heart catheterization

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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