NCT00513890已完成不适用
Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis Who Didn't Require Mechanical Ventilation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Clinical score of respiratory distress at base line (H0) and at 6 hours (H6)
研究概览
简要总结
The purpose of the study is to evaluate, in a prospective way, the clinical, the manometric an gazometric benefit of non-invasive ventilation (VNI), (INFANTFLOW [EME, Brighton, England]) during bronchiolitis of the infant compared to a conventional managment.
详细描述
- Experimental plan: The infants (0 to 6 month) admitted in pediatric intesive care unit for respiratory distress with bronchiolitis but not requiring mechanical ventilation are randomized in two groups: group "A" is treated with a non-invasive ventilation device(Infantflow) during 6 hours, group "B" is treated conventionally by inhalation of a Air/O2 mixture during 6 hours.
- Outcome: Primary outcome: clinical score of respiratory distress at H0 and H6. Secondary outcome: respiratory and cardiac frequency, average blood pressure. Manometric: Variation of esophageal pressure at H0, H6. Gasometric: Minimal FiO2 necessary to reach an oxygen saturation between 94 and 98%, transcutaneus PCO2, PaO2/FiO2
- Analyze results: Intention to treat analysis after having checked the randomization by comparing clinical gravity in the two arms (clinical score).
- Calendar of the study: October 2006 at April 2008
- Follow-up of the patients: the study proceeds during the hospitalization of the infants during 6 hours and will not impose any specific follow-up.
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 Day 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant from 0 to 6 months admitted in the PICU
- •Clinical diagnosis: bronchiolitis
- •Signs of respiratory distress evaluated with a clinical score of respiratory distress > 4
排除标准
- •Cardiopathy, cystic fibrosis or a neuromuscular desease
- •Need for mechanical ventilation
结局指标
主要结局
Clinical score of respiratory distress at base line (H0) and at 6 hours (H6)
after the begining of the procedure.
The respiratory distress was evaluated with the modified Woods Clinical Asthma
Score (m-WCAS) [Hollman G, Shen G, Zeng L, et al. Crit Care Med 1998; 26:1731-1736]
次要结局
- and 98%, transcutanée PCO2, PaO2/FiO2
- Manometric: Variation of esophageal pressure at H0 and H6.
- Gasometric: Minimal FiO2 necessary to reach an oxygen saturation between 94
- Clinical items: respiratory and cardiac rate, average blood pressure at H0 and H6.
研究者
研究点 (1)
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