跳至主要内容
临床试验/NCT01062685
NCT01062685已完成不适用

Near Infrared Spectroscopy (NIRS) to Measure Tissue Oxygen Saturation (St02)

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
186
试验地点
1
主要终点
Organ Dysfunction and Severity of Illness

研究概览

简要总结

The overall hypotheses of this project is that Near Infrared Spectroscopy (NIRS) can be used to identify morbidity, mortality, and resource utilization in patients with sepsis and septic shock.

详细描述

Near-infrared spectroscopy (NIRS) noninvasively measures peripheral tissue oxygen saturation (StO2), offering promise as a guide in the early treatment of severe sepsis; however, the role and utility of this technology is still evolving.

There are three main NIRS measurements reported in the literature: continuous StO2 measurement (StO2 initial), StO2 occlusion slope (StO2 downslope) in response to VOT testing and StO2 recovery slope (StO2 upslope) in response to vasoocclusive testing. The purpose of this study is to assesses the association of each of these parameters with severity of illness, organ dysfunction and death.

This study will utilize the Hutchinson InSpectra StO2 tissue oxygenation monitor, which is FDA approved for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle, or when there is a suspicion of compromised circulation.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Listed on the Cohorts description.

排除标准

  • All patient cohorts will share common set of exclusion criteria:
  • Age < 18 years
  • Pregnancy
  • Established "Do Not Resuscitate" orders prior to enrollment
  • Primary diagnosis of:
  • Acute traumatic or burn injury
  • Acute cerebrovascular event
  • Acute coronary syndrome
  • Acute pulmonary edema
  • Cardiac dysrhythmia
  • Acute and active gastrointestinal bleeding
  • Acute drug overdose
  • Requirement for immediate surgery
  • Inability to obtain written informed consent

结局指标

主要结局

Organ Dysfunction and Severity of Illness

时间窗: time 0 - 24 hrs

次要结局

  • Mortality(In hospital)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nathan Shapiro

Associate Professor of Medicine

Beth Israel Deaconess Medical Center

研究点 (1)

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