NAVADYN11 : Hemodynamic Impact of a New Ventilatory Support Mode With Diaphragmatic Synchronization
Despite spectacular advances since the 90s mechanical ventilation used in intensive care units are amply associated with cardio-respiratory complications: nosocomial pneumonia, lung parenchyma lesions induced by ventilation, hemodynamic instability and ultimately to a significant morbidity and mortality.
NAVA (Neurally Adjusted Assist Ventilation) ventilatory support, provides synchronous support, proportionate to patient's respiratory efforts. More "physiological", this mode would decline its efficacy on patient hemodynamic response. However, to date, no study has focused on hemodynamic impact of NAVA. This is precisely the purpose of NAVADYN11 study, which aims to assess NAVA efficacy on cardiac index in pediatric intensive care unit.
研究概览
地位
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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Nantes、法国、44093
- Nantes university hospital
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria:
- Servo-i with NAVA available at patient admission
- Sedation protocol compatible with NAVA functioning
- Parental consent
Non inclusion criteria:
- Digestive pathology incompatible with gastric tube.
- Deep sedation required defined by score ComfortB <11 (cranial traumatism…)
- Brain damage incompatible with spontaneous ventilation
- Duration of intubation too short for investigation
Exclusion criteria:
- Clinical worsening requiring treatment and/or management inconsistent with NAVADYN11 research (CPR, emergency surgery ...). However, the investigator is allowed to reiterate investigation when patient stabilized.
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
|---|---|
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Assess the impact of NAVA ventilation on hemodynamic parameters
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Assess the impact of NAVA ventilation on hemodynamic parameters in children hospitalized in a Paediatric Intensive Care Unit.
Endpoint evaluation consists in a non-invasive measurement of cardiac index by esophageal doppler.
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次要结果测量
结果测量 |
措施说明 |
|---|---|
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血压
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法国国民银行
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心率
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乳酸盐
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Omega score
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SaO2/SaO2-SvO2
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NIRS
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Blood gas
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Perfusion score
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Right cardiac work index
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if available
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合作者和调查者
调查人员
- 首席研究员：Nicolas JORAM, Doctor、Nantes university hospital
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
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 (估计)
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
- 11/6-H
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