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临床试验/NCT01253772
NCT01253772已完成不适用

Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia in Neonates

SterilMed, Inc.0 个研究点目标入组 4 人开始时间: 2010年5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
4
主要终点
SpO2 Accuracy Verification Study (ARMS) of ≤ 3%

研究概览

简要总结

Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples during cardiac surgery.

详细描述

Researchers at the University of California, San Francisco have developed methods that permit them to test multiple pulse oximeter sensors on neonates simultaneously during cardiac surgery. During this type of surgery, the arterial oxygen saturation changes over a wide range, providing an ideal arena for the assessment of neonatal pulse oximeter sensors at many levels of oxygen saturation. Several arterial blood gas samples are typically obtained during these procedures. Saturation of each arterial blood sample is determined by direct oximetry in a hemoximeter and this measurement is compared to the reading displayed on the pulse oximeter.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
— 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Neonatal patient scheduled to undergo cardiac surgery where routine blood draws would be taken
  • Understand and provide signed parental/guardian consent

排除标准

  • Failure to obtain parental consent
  • Patients shown to have an adverse reaction to medical tape/adhesive

结局指标

主要结局

SpO2 Accuracy Verification Study (ARMS) of ≤ 3%

时间窗: During Analysis - data were collected anywhere from the beginning of surgery until the completion of the procedure

次要结局

未报告次要终点

研究者

申办方类型
Industry

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