NCT04836689已完成不适用
Influence of Respiratory Rate Settings on CO2 Levels During Nasal Intermittent Positive Pressure Ventilation (NIPPV).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Trans cutaneous CO2 (TCCO2)
研究概览
简要总结
Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high and low rate of NIPPV, when in a stable condition. NIPPV rate will start high/low, changed to low/high and switched back to starting rate.
详细描述
This will be a prospective, crossover observational study that will be performed at Rambam NICU.
Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high and low rate of NIPPV, when in a stable condition.
NIPPV rate will start high/low, changed to low/high and switched back to starting rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age 240 to
- •At least 6 hours of stabilized NIPPV settings, i.e. minor changes in settings (FiO2 ≤0.10, PIP≤ 2.0 cmH2O, RR≤ 5 brm).
- •At least 6 hours of stabilized tcCO2, i.e. ≤5 mmHg variation.
- •At least 6 hours from surfactant administration.
- •Parental consent
排除标准
- •If NIPPV set rate is 10 bpm and tcCO2 related pCO2 is<40mmHg.
- •If NIPPV set rate is 30 bpm and tcCO2 related pCO2 is>60mmHg.
- •Unstable infants due to acute conditions (sepsis. IVH), or congenital malformations.
结局指标
主要结局
Trans cutaneous CO2 (TCCO2)
时间窗: During the 3 hours of the study
Trans cutaneous CO2
次要结局
未报告次要终点
研究者
Ori Hochwald , MD
Director, NICU
Rambam Health Care Campus
研究点 (2)
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