Pilot Cross-Over Trial of Neurally Adjusted Ventilatory Assist (NAVA) and Conventional Flow Triggered Mechanical Ventilation (CMV) in Severe Bronchopulmonary Dysplasia (sBPD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Oxygen Saturation (SpO2) Index
研究概览
简要总结
This prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation will compare measures of pulmonary mechanics, respiratory gas exchange, and patient comfort between conventional flow triggered mechanical ventilation and neurally adjusted ventilatory assist (NAVA) among 20 prematurely born infants and young children receiving invasive respiratory support for severe bronchopulmonary dysplasia (BPD).
详细描述
Most research to date in neonatal lung disease has focused on bronchopulmonary dysplasia (BPD) prevention. As a result, insufficient investigation has been performed to define optimal respiratory management strategies for infants and young children with established BPD. Thus, there is no robust evidence base to guide ventilator management to promote lung disease recovery and support neurodevelopment in this population. Neurally adjusted ventilatory assist (NAVA) is an alternative to conventional flow triggered ventilation that has shown promise for improving respiratory gas exchange, patient-ventilator interaction, and work of breathing in preterm neonates. The safety and efficacy of NAVA in infants and young children with established, severe BPD is uncertain. This prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation will compare measures of pulmonary mechanics, respiratory gas exchange, and patient comfort between conventional flow triggered mechanical ventilation and NAVA among 20 prematurely born infants and young children receiving invasive respiratory support for severe BPD.
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 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational ages (GA) ≤ 32 weeks
- •Current age between 36 weeks postmenstrual age (PMA) and 2 years corrected age
- •Severe BPD [as per National Institutes of Health (NIH) consensus definition] diagnosed at 36 weeks postmenstrual age
- •Receiving invasive mechanical ventilation for ongoing lung disease
- •Not expected to be ready for extubation within 11 days following enrollment
- •Parental consent
排除标准
- •Severe congenital anomalies
- •Known diaphragmatic defect
- •Current treatment with high frequency mechanical ventilation
- •Do not resuscitate (DNR) Status or Futility of Care
- •>10% leak around the artificial airway,
- •Treatment with neuromuscular blockade within 72 hours prior to enrollment
- •Acute respiratory instability defined as a ventilator rate increase > 15 beats per minute (bpm), Positive end-expiratory pressure (PEEP) increase > 2 cm/water (H2O), sustained FiO2 increase > 20%, and/or prescribed increase in tidal volume > 2 mL/kg within 24 hours prior to enrollment will be excluded.
研究组 & 干预措施
Conventional Flow Triggered Mechanical Ventilation (CMV)
Subjects will be ventilated with conventional mechanical ventilation with data collected for the 5 day time frame to compare to the experimental arm
干预措施: CMV (Device)
Neurally Adjusted Ventilatory Assist (NAVA)
Subjects will be ventilated on neurally adjusted ventilatory assist (NAVA) mode with data collected for the 5 day time frame to compare with placebo arm
干预措施: NAVA (Device)
结局指标
主要结局
Oxygen Saturation (SpO2) Index
时间窗: up to 5 days per study arm
The Oxygenation Saturation Index (OSI) is a composite measure of the severity of hypoxic respiratory failure. It quantifies how much ventilatory support is required to achieve a given level of oxygen saturation. Lower OSI values indicate better oxygenation and better clinical status. Higher OSI values indicate worse oxygenation and more severe respiratory failure. Oxygen saturation index will be measured by assessing if invasive mechanical ventilation with NAVA compared to CMV improves respiratory gas exchange in patients receiving invasive respiratory support for BPD. This will be calculated as the mean, time-weighted daily oxygen saturation (SpO2) index (\[mean airway pressure x Fraction of inspired oxygen (FiO2)\]/SpO2).
次要结局
- Sedation Medications(up to 5 days per study arm)
- Stress(up to 5 days per study arm)