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