Crossover Comparison of Tidal Volume Delivery During Nasal Intermittent Positive Pressure Ventilation in Preterm Infants: Infant Cannula vs. Nasal Continuous Positive Airway Pressure Prongs
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Relative tidal volume delivery, breath type I
研究概览
简要总结
Crossover bedside clinical study to examine relative tidal volume delivery during nasal intermittent positive pressure ventilation (NIPPV) and directly compare the RAM® infant cannula to a nasal continuous positive airway pressure (nCPAP) delivery system in vivo. The study population will consist of preterm neonates with mild respiratory insufficiency who are receiving NIPPV, non-invasive neurally adjusted ventilatory assist (NIV NAVA), or nCPAP.
详细描述
Bedside crossover study of neonates with mild respiratory distress receiving NIPPV. Infants serve as their own controls and are randomized to initial interface of either RAM® infant cannula or Miniflow® nCPAP prongs. Infants are instrumented with the following monitoring equipment: Edi orogastric tube to measure electrical activity of the diaphragm, transcutaneous monitor to measure transcutaneous CO2 and O2, pulse oximeter to measure heart rate and oxygen saturation, and respiratory inductance plethysmography (RIP) bands around the chest and abdomen to measure breathing movements and relative Vt (arbitrary units, a.u.). Data are continuously and simultaneously acquired using a data acquisition system. After 10 minutes of stabilization, infants receive 5 minutes of NIPPV on each of a sequence of four commonly used pressure settings (expressed as peak inspiratory pressure / positive end expiratory pressure): 16/5, 16/8, 20/5, 20/8. This sequence is not randomized and is constant between interfaces. Subjects are then placed on the alternate interface, and the sequence is repeated. Events ("breaths") are separated into 3 types: patient effort synchronized with NIPPV breaths (type I), NIPPV breaths without patient effort (type II), and patient effort without NIPPV breaths (type III).
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
- — 至 28 Days(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronologic age less than 28 days
- •Gestational age at birth between 24 weeks 0 days to 34 weeks 6 days
- •Currently receiving NIPPV, NIV NAVA, or nCPAP
排除标准
- •Oxygen requirement greater than 40%
- •Peak inspiratory pressure greater than 20 cm H2O
- •Major congenital anomalies of the heart or lungs
结局指标
主要结局
Relative tidal volume delivery, breath type I
时间窗: 1 hour
Relative tidal volume measured in arbitrary units (AU) via RIP bands during synchronized breaths
Relative tidal volume delivery, breath type II
时间窗: 1 hour
Relative tidal volume measured in arbitrary units (AU) via RIP bands during ventilator-driven breaths
Relative tidal volume delivery, breath type III
时间窗: 1 hour
Relative tidal volume measured in arbitrary units (AU) via RIP bands during patient-driven breaths
次要结局
- Heart rate(1 hour)
- Ventilator pressure delivery(1 hour)
- Ventilator flow delivery(1 hour)
- Oxygen saturation(1 hour)
- Transcutaneous carbon dioxide tension(1 hour)
- Transcutaneous oxygen tension(1 hour)
研究者
Ashley L. Lynch
Principle Investigator
Arkansas Children's Hospital Research Institute
