NCT04208906已完成不适用
Validation of Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Validation of Masimo O3 value
研究概览
简要总结
We evaluate the relationship between the regional tissue oxygenation value (ScO2 - cerebral, StO2 - lower limb) and mixed venous saturation (SvO2) and arterial oxygen saturation (SaO2) measured before and after correction surgery in pediatric patients undergoing cardiac surgery.
In addition, we compared the sCO2 and sTO2 with reference value which is calculated using SvO2 and SaO2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children under 7 years old
排除标准
- •Hyperbilirubinemia
- •Skin disease at sensor attachment site
- •Single ventricle physiology
结局指标
主要结局
Validation of Masimo O3 value
时间窗: During surgery
Comparison of ScO2 and StO2 to reference level (SvO2, 0.7×SvO2 + 0.3×SaO2)
次要结局
未报告次要终点
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital
研究点 (2)
Loading locations...
相似试验
终止
不适用
Performance Comparison of Masimo O3 Regional Oximetry Sensors in NeonatesRegional Saturation of Oxygen (rSO2)NCT03828487Masimo Corporation8
已完成
不适用
Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and ChildrenSurgeryNCT03123354Masimo Corporation44
已完成
不适用
Validation of the O3 Regional Somatic Tissue Oxygenation MonitorOxygen DeficiencyNCT04584788Masimo Corporation37
已完成
不适用
A comparison of cerebral oxygenation as measured by the O3, the NIRO 200 and the INVOS 5100 Near-Infrared Spectrophotometershealthy volunteersJPRN-UMIN000029059Yamagata University9
尚未招募
不适用
Regional cerebral oximetry monitoring and incidence of postoperative cognitive dysfunction in elderly patients undergoing complex spine surgeryPostoperative cognitive dysfunctionPostoperative cognitive dysfunction,NIRSTCTR20191018001no168