NCT03109613终止1 期
Selecting PEEP in Ventilated Premature Infants by Reducing Ventilation/Perfusion Mismatch: a Pilot Feasibility Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 6
- 主要终点
- Feasibility assessed by rate of successfully study enrollment and completion
研究概览
简要总结
Positive end-expiratory pressure (PEEP) is used in premature infants receiving mechanical ventilation to maintain lungs open and facilitate gas exchange. When ventilation/perfusion mismatch is present, areas of the lung that are open for gas exchange do not match up with areas of the lung that are receiving blood for gas exchange. This study measures the feasibility of enrolling and completing study maneuvers in premature infants for a prospective study measuring the responsiveness of V/Q mismatch to changes in the amount (or level) of PEEP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm birth before 32 weeks gestational age by best obstetric estimate, determined by the clinical obstetric team during antepartum admission
- •Birth weight less than 1500 grams, as measured by the clinical team at neonatal admission.
- •Presence of endotracheal intubation and invasive mechanical ventilation
- •Less than or equal to 28 days chronologic age
- •Supplemental oxygen requirement, with a fraction of inspired oxygen (FiO2) equal to or greater than 0.25 as documented on the bedside infant flow sheet.
排除标准
- •Congenital anomalies, as determined by the clinical supervising physician
- •Current of prior air leak syndrome, as determined by the clinical supervising physician.
- •Non-English speaking parents
- •Non-viable birth, as determined by the clinical supervising physician
结局指标
主要结局
Feasibility assessed by rate of successfully study enrollment and completion
时间窗: Full enrollment (12 subjects)
Rate of successfully study enrollment and completion
次要结局
- Ventilation/perfusion mismatch(10-20 minutes following each PEEP level change)
研究者
研究点 (6)
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