Application of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants and Assessment of Its Benefits Compared to Synchronized Intermittent Mandatory Ventilation (SIMV) With Pressure Support (PS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Peak Inspiratory Pressure
研究概览
简要总结
The purpose of this study is to test the hypothesis that neurally adjusted ventilatory assist (NAVA) will allow to lower the ventilator pressure at equivalent fractions of inspiratory oxygen (FiO2) and partial pressure of CO2 of capillary blood in preterm infants in comparison with currently used standard ventilation (synchronized intermittent mandatory ventilation with pressure-support ventilation, SIMV+PSV).
详细描述
The investigators will apply crossover comparison in preterm infants who received a ventilatory support. In patient whose frequency of mandatory support is under 25, the two ventilatory modes (SIMV+PSV and NAVA) are delivered by the same ventilator (Servo-I; Maquet Critical Care AB, Solna, Sweden) and will set to maintain similar blood gas analysis results.
Determination of the type of ventilatory mode used is performed using a cluster randomization. The randomized order of ventilatory mode will be used during total 9 hours; one mode for 4 hours and another mode for 5 hours. To rule out carry-over effects, a 1-hour interval for washout was guaranteed between modes. Recordings will be obtained over a total 8 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infants mechanically ventilated
- •ventilatory set frequency is under 25
- •with informed consent of their parents
排除标准
- •major congenital anomalies
- •patients without self respiratory effort
- •use of sedative or anesthetic drugs
- •grade III or IV intraventricular hemorrhage
- •phrenic nerve palsy or insufficiency
研究组 & 干预措施
ventilator assist
干预措施: neurally adjusted ventilatory assist (NAVA) ventilator mode (Procedure)
结局指标
主要结局
Peak Inspiratory Pressure
时间窗: four hours
peak inspiratory pressure measured by a ventilator for 4 hours with each ventilator mode
次要结局
- Minute Ventilation(four hours)
- Expiratory Tidal Volume(four hours)
- Mean Airway Pressure(four hours)
- Dynamic Compliance(four hours)
- Work of Breathing(four hours)
- Capillary Blood pCO2(four hours)
- Capillary Blood pO2(four hours)
- Peak EAdi(four hours)
- Fraction of Oxygen(four hours)
- Capillary Blood pH(four hours)
- Capillary Blood HCO3(four hours)
研究者
Han-Suk Kim
Assist Professor
Seoul National University Hospital