Comparison of Two Nasal Interface for Continuous Distending Airway Pressure in Preterm Infants: RAM Nasal Cannula and Hudson Prongs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- The difference between set pressure and measured pressure with RAM cannula and Hudson prong
研究概览
简要总结
Continuous distending airway pressure (CPAP) has gained popularity as a means to provide non-invasive respiratory support in neonates to reduce ventilator induced lung injury (VILI). However, maintaining CPAP in preterm infants has been challenging, often related to issues with nasal interface such as nasal septal injury, problems with keeping the prongs in the nose and leak around the prongs with are important factors in proving effective CPAP. RAM cannula was recently approved for providing supplemental oxygen and soon adapted by many centers to provide CPAP in preterm infants. Concerns have been raised that RAM cannula interface results in sub-optimal pressure delivery compared to standard nasal prongs.
详细描述
Objective:
To compare efficacy of delivering continuous distending pressure in preterm neonates using RAM cannula versus the standard prongs (Hudson prongs) by measuring intra-oral pressure. It is hypothesize that CPAP delivered with RAM cannula is comparable to pressure delivered via standard nasal interface in routine clinical practice; and the desired CPAP level is often not achieved in presence of variable leak from mouth irrespective of type of nasal interface.
Aim 1: Compare the level of CPAP in oral cavity between RAM cannula and Hudson prong nasal interface in preterm Hypothesis: The intraoral pressure with CPAP will not be different with use of RAM cannula or Hudson prong nasal interface
Aim 2: Evaluate the effect of nasal interface (RAM cannula and Hudson prong) on respiratory variables Hypothesis: There will be no difference in respiratory variables with CPAP delivered by RAM cannula compared to Hudson prongs.
Method:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 48 Hours 至 52 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any preterm with respiratory distress requiring CPAP but not mechanical ventilation or NIPPV will be eligible for the study. We will recruit preterm infant more than 48 hours old and stable on bubble CPAP
排除标准
- •Infants with major congenital anomalies, neuromuscular disorders, upper airway anomalies, critically sick infants
结局指标
主要结局
The difference between set pressure and measured pressure with RAM cannula and Hudson prong
时间窗: one hour
Intraoral pressure measure using a differential pressure transducer with RAM cannula and then with Hudson prongs
次要结局
未报告次要终点