跳至主要内容
临床试验/NCT01891188
NCT01891188已完成不适用

Using Near-infrared Spectroscopy (NIRS) Monitor to Noninvasively Evaluate Hepatic Venous Saturation

Phoenix Children's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年6月1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
100
试验地点
1
主要终点
Degree of Hepatic Venous Saturation using NIRS

研究概览

简要总结

Clinical studies are required to validate the hepatic NIRS monitor with other regional and global hemodynamic parameters and to evaluate its clinical use for continuous non-invasive hemodynamic monitoring. Using newer NIRS sensors the correlation between hepatic regional oxygen saturation and hepatic venous oxygen saturation (SvHO2) needs to be determined. If found to correlate then the NIRS can be used to evaluate early liver transplant failure and/or hepatic artery thrombosis, used as an early marker for shock, and necrotizing enterocolitis, and finally used in the outpatient setting to evaluate patients with chronic liver pathologies. If our validation study finds that NIRS monitors are an appropriate marker of hepatic venous saturation then it will lead to further clinical studies.

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
1 Day 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All pediatric patients (0-18yrs) undergoing cardiac catheterization by the participating interventional cardiologist at Phoenix Children's Hospital will be recruited for this investigation

排除标准

  • •emergency catheterizations,
  • •procedures in hemodynamically unstable patients,
  • •patients with repeat catheterizations that have already enrolled in the study

研究组 & 干预措施

Cardiac Cath

All pediatric patients requiring cardiac catheterization who consent

结局指标

主要结局

Degree of Hepatic Venous Saturation using NIRS

时间窗: 5 minutes

The investigators strive to discover a noninvasive measure of hepatic venous saturation. The use of NIRS monitoring for global oxygen saturation has been used in the inpatient population. This project aims to use hepatic NIRS monitor as a surrogate marker for hepatic and splanchnic oxygenation.

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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