High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths in Neonate: Effect on Carbon Dioxide Level
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Arterial pCO2 Level
研究概览
简要总结
The goal of this clinical trial is to the short-term effects of sigh breaths during High-frequency oscillatory ventilation (HFOV) in neonate undergoing mechanical ventilation. From meta-analysis, It revealed HFOV in neonates could reduce chronic lung disease or death rather than conventional ventilation.
The main question it aims to answer is: Do sigh breaths augment restoring lung volume and ventilation (CO2 level) in intubated neonate with HFOV? Participants will be applied sigh breaths (HFOV-sigh) during on HFOV. Researchers will compare HFOV-sigh mode to see if CO2 level (before-after intervention).
详细描述
Sample size calculation (before and after intervention: two dependent mean)
- alpha = 0.05, beta = 0.2,
- Delta = 1.9, SD. = 4.35
- Calculated sample size = 42
- increase sample size if loss follow up 20%
- Final sample size (n) = 50
Subgroup analysis for
- preterm neonates
- very preterm or very low birth weight neonates
- extremely preterm or extremely low birth weight neonates
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm and term neonate (gestational age 24-41 weeks) with postnatal age less than 28 days
- •Already ventilated with high frequency ventilation at least 1 hours
- •An umbilical or peripheral arterial catheterization was available
排除标准
- •Previous or current pulmonary air leaks (pulmonary interstitial emphysema, pneumothorax, pneumomediastinum, and pneumopericardium)
- •Heterogeneous lung disease including MAS, congenital diaphragmatic hernia
- •Suspected lung hypoplasia
- •Suspected or confirmed intraventricular hemorrhage grade III-IV
- •Suspected or confirmed hypoxic ischemic encephalopathy or 5-min Apgar score less than 3
- •Hemodynamic instability despite using inotrope(s)
- •Arterial pCO2 level less than 45 mm Hg or more than 70 mm Hg before intervention
- •Need a new arterial puncture for samples both before and after interventions
- •Moribund status
- •Parents' decision not to participate
结局指标
主要结局
Arterial pCO2 Level
时间窗: before sigh (baseline) and after sigh (2 hours)
ABL800 BASIC (Radiometer Medical ApS™, Denmark) analyzed all blood gas samples within 1 min after collection. The blood gas machine was auto-calibrated every 4 h by trained specialists every day.
次要结局
- Oxygenation(before sigh (baseline) and after sigh (2 hours))
- Mean Airway Pressure(2 hours after sigh breaths)
研究者
Anucha Thatrimontrichai
Office of Human Research Ethics Unit
Prince of Songkla University