NCT01953562撤回不适用
Evaluation of the Influence of Positioning and Time Duration on the Spontaneous Breathing Test in Neonates
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Effect of prone vs supine positioning on whether an infant receives a passing score on the SBT test
研究概览
简要总结
The spontaneous breathing test (SBT) is routinely performed on all intubated patients in the NICU who are potential candidates for extubation from mechanical ventilatory support. For all parents who consent, the routine SBT will be performed on all infants. In addition to the routine SBT the following will occur:
- work of breathing indices: obtained non-invasively through respiratory inductive plethysmography (RIP).
- Performing the SBT in the prone position, in addition to the routine position (supine).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants who qualify for SBT as part of their normal care
排除标准
- •Previous history of abdominal or chest surgery (i.e. chest tube, PDA ligation, surgical NEC)
- •Congenital malformation of the chest of abdomen
- •Neuromuscular disorder
- •Current medications affecting neuromuscular tone (ex morphine)
- •Unable to be positioned either prone or supine as determined by the attending neonatologist.
结局指标
主要结局
Effect of prone vs supine positioning on whether an infant receives a passing score on the SBT test
时间窗: 30 minutes
SBT is a pass/fail test. The effect of prone vs supine positioning in intubated neonates on whether a spontaneous breathing test is scored pass or fail will be determined.
次要结局
- WOB indices during SBT(10 minutes)
研究者
Robert Locke
Neonatologist
Christiana Care Health Services
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