Cerebral Oximetry in Newborns - Comparing INVOS 5100 and FORE-SIGHT Cerebral Oximeters Absolute Values, Sensitivity for Low Oxygen Levels and Reproducibility..
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Cerebral oxygenation
研究概览
简要总结
Regional tissue oxygenation (rStO2) can be monitored by near infrared spectroscopy. The commercial devices FORE-SIGHT (CASMED) and INVOS (COVIDIEN) will be used simultaneously to test for their relative sensitivity for low oxygen levels just after birth on term infants born by elective cesarean section. Reproducibility will be examined by replacements of the sensors six times the next day when the infant is stable and quiet. Neonatal sensors will be used.
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
- — 至 2 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term infants (age more than 37 weeks of gestation)
- •Elective cesarean section after an uncomplicated pregnancy
- •Exclusion criteria:
- •Thick hair that makes good measurements difficult/impossible
- •Obvious malformations or syndrome
- •Complications in relation to the cesarean section
- •Depression after birth (APGAR < 8 after 1 minute)
排除标准
- 未提供
结局指标
主要结局
Cerebral oxygenation
时间窗: 10 minutes
The sensors of both instruments will be placed on each side of the head. They will be held by hand or by self-adhesive tape as appropriate. Curve fitting will be used to describe the rapid increase of oxygenation after birth. Estimated cerebral oxygenation at 3 min (hypoxia) and 10 min (normoxia) will be used to compare the two instruments.
次要结局
- Reproducibility(10 minutes)
研究者
Gorm Greisen
Professor, MD
Rigshospitalet, Denmark