NCT03599973Unknown不适用
Corrélation Entre la Longueur de jeûne et la réponse au Remplissage Vasculaire évaluée Par Des Mesures répétées de l'ITV.
Erasme University Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年8月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Aortic VTI change
研究概览
简要总结
The investigators will study the correlation between the lenght of the fasting before surgery and the need to replenish with intra-venous fluids in children, evaluated with 3 measures of the aortic Integral Time Velocity with transthoracic echocardiography.
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
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged between 3 and 6 years with a normal ponderal evolution.
- •Children with good general status (ASA 1)
- •Children whose parents have given the informed authorization to do the study.
- •Children seen in the consultation of anesthesiology.
- •Children programed to have ambulatory surgery (Amygdalectomy, dental care, dental extraction).
排除标准
- •Children with more than 6 years of age.
- •Children whose parents didn't agree with the study.
- •Children enrolled in another study on the 3 months before.
- •Children with hearth or lung conditions.
研究组 & 干预措施
Patient
Other
One-arm study, where all patients are given the same standard fluidotherapy and anesthetic conditions to compare measures of Aortic VTI before and after the IV fluid.
干预措施: Plasmalyte A Viaflo (Other)
结局指标
主要结局
Aortic VTI change
时间窗: From baseline analysis (t=5 min after anesthesia induction), to the end of fluid therapy (t=20 min).
Transthoracic echocardiography measures of the Time-Speed Interval in the aortic valve before fluid therapy (baseline) and after fluid therapy (20 ml/kg in 15 minutes).
次要结局
- Blood pressure change(From baseline analysis (t=5 min after anesthesia induction), to the end of fluid therapy (t=20 min).)
- Legs-up maneuver(From baseline analysis (t=5 min after anesthesia induction), to the end of legs-up maneuver (t = +/- 10 min).)
- Post-operative nausea and vomiting(From arrival at PACU (end of surgery) until discharge from PACU (tipically after 1 to 2 hours after the arrival to the PACU))
研究者
研究点 (2)
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