Effect of Changing Levels of Neurally Adjusted Ventilatory Assist (NAVA) on Respiratory Parameters in Newborns Receiving NAVA Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Optimal NAVA level to unload the diaphragm
研究概览
简要总结
To examine the effect of changing levels of support during NAVA-ventilation ("NAVA-level") on electrical diaphragm activity of the newborn on invasive or non-invasive NAVA ventilation.
The aim is to explore whether a so-called 'breakpoint', as defined in previous studies on NAVA ventilation in adults and children(1, 9), can be determined in newborn infants. Knowledge of this breakpoint will be used to optimise the settings of NAVA level at initiation of invasive or non-invasive NAVA ventilation.
This is an explorative study conducted in preparation of a randomized controlled trial that is planned in the near future to compare the effects of non-invasive NAVA with nasal continuous positive airway pressure (CPAP) in newborn infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 20 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns admitted to the NICU in need for respiratory support and put on invasive or non-invasive NAVA by the attending physician. Patients will be included when they are clinically stable and within 24h after starting NAVA or nivNAVA.
排除标准
- •- Congenital malformations of the diaphragm or respiratory system, including congenital diaphragmatic hernia.
- •Patients with abnormalities of the upper airway (e.g. vocal cord paralysis, post-extubation laryngeal edema, Pierre-Robin sequence...).
- •More than 20% of time spent in back-up ventilationWhen a patient on NAVA ventilation is apneic for a certain period of time (apnea time), the ventilator switches tot backup-ventilation. Backup-ventilation is pressure controlled, the apnea time can variate between 2 and 10 seconds.
- •Clinically unstable patients:
- •hemodynamic instability as defined by need of inotropic support or
- •rapid respiratory deterioration on NAVA ventilation.
- •No informed consent.
结局指标
主要结局
Optimal NAVA level to unload the diaphragm
时间窗: 24 minutes
The aim is to explore whether a so-called 'breakpoint', as defined in previous studies on NAVA ventilation in adults and children(1, 9), can be determined in newborn infants. Knowledge of this breakpoint will be used to optimise the settings of NAVA level at initiation of invasive or non-invasive NAVA ventilation.
次要结局
未报告次要终点
研究者
Julie Lefevere
Resident
Universitair Ziekenhuis Brussel