Physiologic Comparison Between Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) and Pressure Support (PS) in Preterm Infants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Trigger Delay
研究概览
简要总结
Neurally adjusted ventilatory assist (NAVA) has been shown to improve patient- ventilator interaction and reduce asynchronies. This is a short-term physiologic comparison between PSV (pressure support ventilation) and NAVA in delivering noninvasive ventilation through a nasal cannula, in premature infants postextubation. Patients will undergo a 30-min crossover trial of noninvasive PSV and NAVA, 15 minutes each. Diaphragm electrical activity (EAdi)and airway pressure (Paw) are recorded to derive neural and mechanical respiratory rate and timing, inspiratory trigger delays time of synchrony between diaphragm contraction and ventilator assistance, and the asynchrony index (AI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Days 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infants less than 32 weeks of gestational age
- •intubated more than 48 hours after birth
- •subjected to extubation with minimal ventilator setting (mean airway pressure < 7cmH2O + peak inspiratory pressure < 13 cmH2O + FiO2 < 0.4 + respiratory rate < 35/min)
- •with informed consent from parents
排除标准
- •with major congenital anomalies
- •use of sedative or anesthetic drugs
- •hemodynamic instability
- •grade 3 or higher intraventricular hemorrhage
- •phrenic nerve palsy
研究组 & 干预措施
NAVA-PS
noninvasive NAVA first for 15 minutes and then PSV for 15 minutes
干预措施: noninvasive respiratory support with NAVA mode and PSV (Device)
PS-NAVA
noninvasive PSV first for 15 minutes and then NAVA for 15 minutes
干预措施: noninvasive respiratory support with NAVA mode and PSV (Device)
结局指标
主要结局
Trigger Delay
时间窗: last 5-min of each 15-min trial
Inspiratory trigger delay could be calculated by the time interval between beginning of the increase of actual diaphragmatic excitation and start of ventilator inspiratory flow of each respiration. The value will be present as a mean of all inspiratory trigger delay measurements of all respiration during last 5 minutes of each 15 minutes trial.
次要结局
- Ti_excess (Inspiratory Time in Excess)(last 5-min of each 15-min trial)
- Heart Rate(last 5-min of each 15-min trial)
- Pneumatic Respiratory Rate(last 5-min of each 15-min trial)
- Leakage(last 5-min of each 15-min trial)
- Blood Pressure(last 5-min of each 15-min trial)
- SpO2(last 5-min of each 15-min trial)
- Respiratory Rate(last 5-min of each 15-min trial)
- Minute Ventilation Volume(last 5-min of each 15-min trial)
- Peak Inspiratory Pressure(last 5-min of each 15-min trial)
- Maximum EAdi(last 5-min of each 15-min trial)
- Swing EAdi(last 5-min of each 15-min trial)
- All Asynchrony Events(last 5-min of each 15-min trial)
- Asynchrony Index(last 5-min of each 15-min trial)
研究者
Han-Suk Kim
MD, PhD
Seoul National University Hospital