跳至主要内容
临床试验/NCT02124551
NCT02124551已完成不适用

Comparing PVI Measurements at Different Sensing Locations

University of California, Irvine1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2014年4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
35
试验地点
1
主要终点
PVI measurement of fluid responsiveness

研究概览

简要总结

The purpose of this study is to assess the suitability of the ear and forehead as a better site for measure of fluid responsiveness.

详细描述

The aim of this study is to compare Pleth Variability Index (PVI) measurements at different sensor locations in respect to signal quality, sensor fit to site location and fluid responsiveness. PVI will be measured at 3 different sensor sites: the fingers, ear lobes and forehead. The ability to predict fluid responsiveness will be analyzed using cardiac output as the reference value.

研究设计

研究类型
Observational
观察模型
Other
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

  • 18 years of age or older
  • Undergo any type of surgeries under general anesthesia in UCI Medical Center
  • Mechanically ventilated during surgery
  • Arterial line placement is preferred but not required
  • Agree to sign the consent and HIPAA forms

排除标准

  • Less than 18 years of age
  • Pregnant women
  • Refused to sign the consent and HIPAA forms
  • Receive vasoactive medication prior to surgery
  • Has these conditions: hypotension, hypothyroidism, moderate or poorly controlled hypertension, chronic poorly-controlled diabetes, heart failure patients, and patients with active airway flow obstruction, left ventricular dysfunction, intra-cardiac shunts, right ventricular dysfunction, atrial fibrillation, arrhythmias
  • patients with surgeries at or around site of sensor placement
  • Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent monitoring of SpO2 levels during the study

结局指标

主要结局

PVI measurement of fluid responsiveness

时间窗: Intra-operative

The primary outcome is to test the ability of PVI recorded at the finger and at the ear to predict fluid responsiveness.

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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