Automatic Oxygen Administration in Spontaneous Ventilation During the Hypoxemic Acute Respiratory Distress in Infants and Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment
研究概览
简要总结
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
- 1 Month 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment
时间窗: 6 hours or 1 hour after cessation of oxygenation
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.
次要结局
- Time spent in a area of severe desaturation (SpO2 <92%) and a hyperoxia area (SpO2> 98%).(6 hours or 1 hour after after cessation of oxygenation)
- nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures(6 hours or 1 hour after oxygenation cessation)
- Oxygen consumption measured at the end of administration(6 hours or 1 hour after cessation of the oxygenation)
- Number of complications related to the administration of oxygen(28 days max)
- Frequency of use of invasive or noninvasive ventilation during hospitalization(28 days max)