The Influence of Two Different Premedication Protocols for Endotracheal Intubation in Neonates on Cerebral Oxygenation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change of cerebral tissue oxygen saturation during premedication and intubation
研究概览
简要总结
The purpose of this study is to examine the influence of premedication drugs Atropin, Fentanyl and Mivacurium and of endotracheal intubation on cerebral oxygenation and cardiac output in term and preterm newborn infants. Two different protocols of premedication are compared.
详细描述
Influence of the following procedures will be examined:
- Application of Atropin
- Application of Fentanyl
- Application of Mivacurium
- possible desaturation and / or bradycardia during intubation attempts
- restoration of arterial oxygen saturation and / or heart rate after succesful intubation
We aim to examine the change of the following parameters by the use of electrical cardiometry:
- stroke volume
- cardiac output
We compare two different premedication protocols and we evaluate the impact of these protocol on the time needed for intubation and on intubation difficulties .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 44 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newborn infant below 44 weeks postmenstrual age
- •indication for elective or semi-elective endotracheal Intubation
- •parental informed consent
排除标准
- •emergency intubation
研究组 & 干预措施
Relaxation followed by analgosedation
Give Atropin, then Mivacurium, immediately followed by Fentanyl
干预措施: Atropine, Fentanyl, Mivacurium (Drug)
Analgosedation followed by Relaxation
Give atropin, then Fentanyl, then Mivacurium
干预措施: Atropine, Fentanyl, Mivacurium (Drug)
结局指标
主要结局
Change of cerebral tissue oxygen saturation during premedication and intubation
时间窗: from 1 minute before first study drug until 10 minutes after end of procedure
A baseline value of cerebral tissue oxygen saturation before first application of premedication drugs is determined. Change of cerebral tissue oxygen saturation is defined as area under this threshold from first drug application until recovery.
次要结局
未报告次要终点
研究者
Manuel Schmid
Dr. med.
University of Ulm