NCT01274845已完成不适用
Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome
Poznan University of Medical Sciences2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2006年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Changes in acid-base balance and oxygenation
研究概览
简要总结
The aim of the study: to assess the effect of short-term mechanical ventilation with heliox in newborns with meconium aspiration syndrome on vital signs, oxygenation, acid-base balance and respiratory function parameters.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meconium aspiration syndrome diagnosed based on clinical and radiological findings,
- •respiratory failure requiring mechanical ventilation
排除标准
- •congenital malformations or congenital genetic syndromes,
- •persistent pulmonary hypertension of the newborn (PPHN) requiring inhaled nitric oxide treatment
结局指标
主要结局
Changes in acid-base balance and oxygenation
时间窗: Parameters recorded first at the baseline during ventilation with air-oxygen gas mixture, then after 15 and 60 minutes of the heliox ventilation and finally 15 and 60 minutes after switching back to air-oxygen ventilation.
Acid-base balance and oxygenation assessed on arterial blood gas samples, saturation measured with a pulse oximeter and calculated values of oxygenation index and alveolar-arterial oxygen tension difference.
次要结局
- Changes in respiratory parameters(Parameters recorded first at baseline during ventilation with air-oxygen gas mixture, then after 15 and 60 minutes of the heliox ventilation and finally 15 and 60 minutes after switching back to air-oxygen ventilation.)
研究者
研究点 (2)
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