Optimal High CPAP Pressures in Preterm Neonates Post-extubation: A Prospective Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Peak Edi
研究概览
简要总结
Use of continuous positive airway pressure (CPAP) in preterm neonates has traditionally been limited to between 5-8 cmH2O. In recent years, use of CPAP pressures ≥9 cmH2O is becoming more common in neonates with evolving chronic lung disease, in lieu of other non-invasive modes or invasive mechanical ventilation. A particular knowledge gap in the current literature is the choice of the level of pressure level when using High CPAP as a post-extubation support mode. In this study, we will comparatively evaluate the short-term impact of two different high CPAP pressures when used as a post-extubation support mode in preterm neonates.
详细描述
Background: Use of continuous positive airway pressure (CPAP) in preterm neonates has traditionally been limited to between 5-8 cmH2O. In recent years, use of CPAP pressures ≥9 cmH2O is becoming more common in neonates with evolving chronic lung disease, in lieu of other non-invasive modes or invasive mechanical ventilation. However, there are limited data on the effectiveness and safety of this mode.
A particular knowledge gap in the current literature is the choice of the level of pressure level when using High CPAP as a post-extubation support mode. While it could be argued that the initial High CPAP pressure post-extubation should be somewhat higher than the pre-extubation mean airway pressure (Paw), there remain concerns of potential complications as well as uncertainty around degree of leak and resulting effectiveness. On the other hand, a suboptimal post-extubation High CPAP level may lead to atelectasis and contribute towards extubation failure, potentially prolonging invasive ventilation and associated risks. As such, research towards identification of the optimal High CPAP level post-extubation from high invasive ventilation pressures is warranted.
Objective
To comparatively evaluate the short-term impact of two different high CPAP pressures when used as a post-extubation support mode in preterm neonates.
Hypothesis
We hypothesize that babies extubated from invasive mechanical ventilation with a mean Paw between 9-15 cmH2O will demonstrate better physiological and clinical parameters when using High CPAP+2 cmH2O vs equivalent CPAP levels.
Methods: Design - This will be a prospective, single-centre, randomized cross-over study.
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
- None
入排标准
- 年龄范围
- 7 Days 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age <29 weeks; chronological age >7 days; post-menstrual age <37 weeks; extubation from invasive ventilation with measured mean airway pressure 9-15 cmH2O
排除标准
- •Any congenital or genetic/chromosomal abnormality
结局指标
主要结局
Peak Edi
时间窗: 60 min following each CPAP level - assessed over 10 min
The peak electrical diaphragmatic activity - a surrogate for work of breathing to generate tidal volume
次要结局
- Minimum EDi(60 min following each CPAP level - assessed over 10 min)
- Regional cerebral perfusion(60 min following each CPAP level - assessed over 10 min)
- Pressure level - Ventilator(60 min following each CPAP level - assessed over 10 min)
- Pressure level - Interface(60 min following each CPAP level - assessed over 10 min)
- Work of breathing score(Over entire duration (70 min) at each CPAP level, assessed every 10 min)
- Heart Rate(Over entire duration (70 min) at each CPAP level, assessed every 10 min)
- Respiratory Rate(Over entire duration (70 min) at each CPAP level, assessed every 10 min)
- Transcutaneous CO2 level(Over entire duration (70 min) at each CPAP level, assessed every 10 min)
- FiO2 level(Over entire duration (70 min) at each CPAP level, assessed every 10 min)
- Number of bradycardic episodes <80 bpm(Over entire duration (70 min) at each CPAP level)
- Proportion of duration with SpO2 <90%(Over entire duration (70 min) at each CPAP level)
研究者
Amit Mukerji
Associate Professor
McMaster Children's Hospital