Effects of Automated Adjustment of Inspired Oxygen on Fluctuations of Regional Cerebral and Arterial Oxygenation in Preterm Infants With Frequent Desaturations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Cerebral tissue oxygen saturation
研究概览
简要总结
In this study the investigators test the hypothesis that automated FiO2 adjustment increases the time of brain tissue oxygenation within the intended reference range. Furthermore, the investigators studied the change in workload during automated FiO2 adjustment as compared to manual adjustment by the nursing staff.
详细描述
Recorded data on brain tissue oxygenation will be compared with reference data obtained from other studies. Data from experimental mode (automated FiO2 control will be compared with manual FiO2 control).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 96 Hours 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •postmenstrual age <30 wks GA at study time
- •on nasal/nasopharyngeal CPAP or mechanical ventilation (including nasopharyngeal IMV)
- •at least 4 desaturations (SpO2 <80%) during an 8 hour period within the 24h before the study using a standard pulse oximeter incorporated in the NICU (Dash 3000, General Electric, Freiburg; 10s averaging time, delay 10s)
排除标准
- •postnatal age <96h (to exclude rapidly changing conditions during the early phase of RDS and to avoid handling of the infant during the critical period for IVH)
- •congenital cyanotic heart disease
- •no decision for full treatment support
- •Average FiO2 during the last 24h bevor the active study phase >0.60
- •Congenital malformations of the lung or the diaphragm (i.e. diaphragmatic hernia, congentital cystic lung diseases...)
- •Clinically clear evidence for seizures
- •Ongoing Sepsis (CRP > 10mg/l, or positive blood culture, requirement of catecholamines)
- •Need of blood-transfusion during study
结局指标
主要结局
Cerebral tissue oxygen saturation
时间窗: 48 hours
mean cerebral tissue oxygen saturation as well als distribution of cerebral tissue oxygen saturation over time will be assessed
次要结局
- number and mean duration of episodes with an SpO2 <80%, <75%, <70% and with hyperoxemia (SpO2 >96%)(48 hours)
- time within a defined target range of cerebral oxygen saturation (59% - 81%)(48 hours)
- workload for the medical staff related to number of adjustments of FiO2(48 hours)
研究者
Prof. Dr. Helmut Hummler
Chief Division of Neonatology and Pediatric Critical Care
University of Ulm