跳至主要内容
临床试验/NCT06004466
NCT06004466招募中不适用

The Development of Novel Noninvasive Internal Jugular Venous Oximetry

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年9月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Internal jugular venous saturation

研究概览

简要总结

In this study, we are developing a novel plethysmographic monitoring device which incorporates several key techniques: inclusion of structural information (ultrasound image), coupling with the estimation of local tissue optical parameters, consideration of the tissue scattering absorption coefficient of each subject, to finally calculate the noninvasive continuous internal jugular venous saturation.

详细描述

Central venous oxygen (ScvO2) is an important index for evaluating tissue perfusion in clinical care. To obtain the ScvO2 value, blood analysis must be obtained through a central venous catheter (CVC). Although CVC placement has a low incidence of complications, however, detrimental complications such as pneumothorax, hemothorax, infection and arrhythmia, are often fatal. In addition, continuous monitoring of ScvO2 often requires expensive equipment, so usually clinical caregivers can only take blood tests at specific care intervals, and may miss the opportunity to detect disease deterioration. In terms of anatomical structure and physiology, the values of internal jugular blood oxygen (SijvO2) and ScvO2 should be very close, and the evidence in the literature also points out that SijvO2 is not only highly similar to ScvO2, but also related to changes in cerebral blood oxygen. The internal jugular vein location is also an easier location for non-invasive continuous monitoring and thus it is interested to develop the novel technique for noninvasive continuous SijvO2 monitoring.

In this study, we are developing a novel plethysmographic monitoring device which incorporates several key techniques: inclusion of structural information (ultrasound image), coupling with the estimation of local tissue optical parameters, consideration of the tissue scattering absorption coefficient of each subject, to finally calculate the noninvasive continuous internal jugular venous saturation.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing major cancer surgery that requires central venous catheter placement
  • Cancer patients undergoing totally implantable venous access device placement

排除标准

  • Susepct infectious symptoms and signs (eg. white blood cell count count >10000 ; fever >38.3℃)
  • impaired liver functions (aspartate aminotransferase> 100 U/L); impaired renal function (estimated glomerular filtration rate <60 mL/min/1.73 m2)
  • heart failure, with New York Heart Associatation class 2 or more

结局指标

主要结局

Internal jugular venous saturation

时间窗: 20 min

To validate the estimation of noninvasive internal jugular venous saturation and the real value by obtaing the internal jugular venous blood during central venous catheter placement

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)

Loading locations...

相似试验