Open Lung Maneuvers During High Frequency Oscillatory Ventilation in Extremely Preterm Infants - A Single Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- HFOV oxygen saturation index
研究概览
简要总结
To assess whether stepwise oxygenation-guided lung recruitment at regular intervals reduces the oxygen saturation index (OSI = Mean Airway Pressure × Fraction of inspired Oxygen × 100 / peripheral Oxygen Saturation, OSI = MAPxFiO2x100/SpO2) averaged over high frequency oscillation ventilation (HFOV) time in extremely preterm infants.
详细描述
Background: Open lung maneuvers aim to recruit and stabilize the majority of collapsed alveoli, using oxygenation as an indirect variable for lung volume. The stepwise oxygenation-guided lung recruitment procedure during frequency oscillatory ventilation (HFOV) in preterm infants has a low risk of lung hyperinflation and air leak syndrome. Nevertheless, open lung maneuvers at regular intervals during HFOV to maintain or restore oxygenation is not implemented as a routine procedure in the neonatal intensive care.
Aim of the study: To assess whether stepwise oxygenation-guided lung recruitment at regular intervals reduces the oxygen saturation index (OSI = Mean Airway Pressure × Fraction of inspired Oxygen × 100 / peripheral Oxygen Saturation, OSI = MAPxFiO2x100/SpO2) averaged over HFOV time in extremely preterm infants.
Study design: Single center randomized controlled study.
Methods: Thirty-six extremely preterm infants below 28 weeks of gestational age and on high frequency oscillation ventilation receive either stepwise oxygenation-guided lung recruitment maneuver at regular intervals (intervention) and upon decision of the care giving team (intervention group) or lung recruitment maneuver only upon decision of the care giving team (standard, control group). The primary outcome is the oxygen saturation index averaged over HFO ventilation time. The observation time of the HFOV will be limited to at most seven days.
Sample size: Fifteen infants need to be enrolled in each group to have 80% power (at a two-sided alpha level of 5%) to detect a difference of 25% in the oxygen saturation index between the intervention group and the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants
- •born below 28 weeks of gestational age
- •not older than 29 weeks of postmenstrual age
- •receive HFOV
排除标准
- •known congenital anomalies of the heart, of the lung, and/or of the central nervous system
- •known chromosomal abnormalities
- •participation in other intervention trials
研究组 & 干预措施
Intervention
lung recruitment maneuvers performed every twelve hours during HFOV
干预措施: regular lung recruitment (Procedure)
Control
no regular lung recruitment maneuvers during HFOV
结局指标
主要结局
HFOV oxygen saturation index
时间窗: through study completion, an average 10 weeks
oxygen saturation index averaged over high frequency oscillation ventilation for not more than seven consecutive days
次要结局
- overall oxygen saturation index(through study completion, an average 10 weeks)
- bronchopulmonary dysplasia(through study completion, an average 10 weeks)
- days of ventilation(through study completion, an average 10 weeks)
研究者
Tobias Werther
Principal Investigator
Medical University of Vienna