Effect of High Frequency Oscillatory Highflow Nasal Cannula on Desaturations and Bradycardia in Preterm Infants: A Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Paired difference in the total number of desaturations and bradycardia between Osciflow and HF
研究概览
简要总结
This study evaluates the effect of non-invasive high frequency oscillations applied via a highflow nasal cannula ('Osciflow') compared to highflow nasal cannula without oscillations (HF) on desaturations and bradycardia in premature infants. It uses a crossover design. Infants are randomized to begin the study with either Osciflow or HF. Both modes are applied for 4 hours. Infants are monitored with an oximetry sensor to measure peripheral oxygen saturation (SpO2) and pulse rate, and with a transcutaneous CO2-transducer. Further measurements include respiratory rate and 'Bernese pain scale' evaluated by nursing staff and Electrical Impedance Tomography (EIT) in a subset of patients.
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
- 3 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born with a gestational age of <35 weeks
- •>72 hours old
- •On nCPAP with PEEP 5 mbar and FiO2 <0.3
排除标准
- •Severe congenital malformations adversely affecting life expectancy
结局指标
主要结局
Paired difference in the total number of desaturations and bradycardia between Osciflow and HF
时间窗: 180-minute recording periods for each therapy
次要结局
- Paired difference in respiratory rate(180-minute recording periods for each therapy)
- Paired difference in heart rate(180-minute recording periods for each therapy)
- Paired difference in fraction of inspired oxygen [FiO2](180-minute recording periods for each therapy)
- Paired difference in peripheral oxygen saturation [SpO2](180-minute recording periods for each therapy)
- Paired difference in the proportion of time spent with oxygen saturations < 80%(180-minute recording periods for each therapy)
- Paired difference in the proportion of time spent with heart rates < 80 bpm(180-minute recording periods for each therapy)
- Paired difference in the number of apneas requiring stimulation(180-minute recording periods for each therapy)
- Paired difference in regional ventilation distribution in a subset of patients.(At the end of each intervention period)
- Paired difference in Tidal volumes in a subset of patients.(At the end of each intervention period)
- Paired difference in nasal trauma score(At the end of each intervention period)
- Paired difference in transcutaneous CO2 measurements(180-minute recording periods for each therapy)
- Paired difference in end-expiratory lung impedance (EELI) in a subset of patients.(At the end of each intervention period)
- Paired difference in pain assessment using 'Bernese pain scale'(180-minute recording periods for each therapy)
- Paired difference in the rate of pneumothorax(180-minute recording periods for each therapy)
- Paired difference in reaching 'failure criteria' to stop Osciflow or HF therapy:(180-minute recording periods for each therapy)