Automatic Oxygen Administration During the Respiratory Distress in Infants and Children (Infant-FreeO2) (Infant-Free02)
Automatic Oxygen Administration in Spontaneous Ventilation During the Hypoxemic Acute Respiratory Distress in Infants and Children
The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in infants and children admitted at hospital for hypoxemic acute respiratory distress.
In healthy volunteers adults, FreeO2 system provided a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. Our hypothesis is that FreeO2 system use is feasible in infants and children with hypoxemic acute respiratory distress. We think FreeO2 will provide a better control of the oxygen saturation, a faster oxygen weaning than classical way (Rotameter). In addition, FreeO2 could reduce the number of intervention by nurses.
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Brest、法国、29609
- CHRU de Brest
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Admission to the emergency for respiratory disease justifying an oxygen administration to maintain a SpO2 ≥ 92%.
- inclusion within a time less than 24 hours after the start of the oxygen at the emergency department.
- written consent of the parents of the child
Exclusion Criteria:
- Necessity of an oxygen flow exceeds 4 L / min to maintain a SpO2 higher than 92%
Criteria of gravity justifying immediately a different technique of ventilatory support:
- Disturbance of consciousness with a Glasgow Coma Score ≤ 12
- Hemodynamic instability (MBP < - 2 DS or need for vasopressors)
- Cardiac or respiratory arrest
- pH < 7.35 and PaCO2 > 55 mm Hg
- Necessity of a urgent surgery
- Age < 1 month
- Respiratory rate > 80 b/min (1 month-2 years old), > 40 b/min (2 - 10 years old) > 30b/min (> 10 years old) ou < 10 b/min
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：人工充氧
氧气手动调节
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其他名称：
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实验性的：Experimental: device FreeO.
Automatic adjustment of oxygen
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其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment
大体时间：6 hours or 1 hour after cessation of oxygenation
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The target zone of oxygen saturation is : SpO2 = 92-98% The "acute phase of treatment" is defined by the 6 first hours of treatment by oxygenation and/or until one hour after the end of this last.
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6 hours or 1 hour after cessation of oxygenation
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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与吸氧相关的并发症数量
大体时间：最多 28 天
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最多 28 天
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Time spent in a area of severe desaturation (SpO2 <92%) and a hyperoxia area (SpO2> 98%).
大体时间：6 hours or 1 hour after after cessation of oxygenation
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6 hours or 1 hour after after cessation of oxygenation
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nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures
大体时间：6 hours or 1 hour after oxygenation cessation
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6 hours or 1 hour after oxygenation cessation
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Oxygen consumption measured at the end of administration
大体时间：6 hours or 1 hour after cessation of the oxygenation
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6 hours or 1 hour after cessation of the oxygenation
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Frequency of use of invasive or noninvasive ventilation during hospitalization
大体时间：28 days max
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28 days max
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Infant-FreeO2
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