NAVADYN11 : Hemodynamic Impact of a New Ventilatory Support Mode With Diaphragmatic Synchronization
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Assess the impact of NAVA ventilation on hemodynamic parameters
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Assess the impact of NAVA ventilation on hemodynamic parameters
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.
次要结局
- NIRS
- Omega score
- Heart rate
- Blood pressure
- Blood gas
- Lactate
- BNP
- Perfusion score
- Right cardiac work index