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临床试验/NCT03870373
NCT03870373已完成不适用

Validate Pulse Oximeter Sensors in Neonates by Comparing Sensor Readings to Blood Samples During Cardiac Surgery

Taiwan Aulisa Medical Devices Technologies, Inc.1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年2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
15
试验地点
1
主要终点
Performance of Pulse Oximeter Sensor in Neonates

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
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
0 Days 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates scheduled to undergo cardiac surgery where routine blood draws would be taken
  • Consent signed by at least one legal guardian

排除标准

  • Presence of any skin irritation or breakdown on the foot
  • Foot impediments which would preclude proper placement of the sensor
  • Clinical condition precluding the use of adhesive materials

结局指标

主要结局

Performance of Pulse Oximeter Sensor in Neonates

时间窗: Data are collected anywhere from the beginning of surgery until the completion of the procedure

Pulse Oximeters - Premarket Notifications Submissions \[510(k)s\] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013)

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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