Effect of Positive Pressure Ventilation on Hemodynamics Around Delayed Sternal Closure Following Stage 1 Palliation of the Single Ventricle
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Oxygen Delivery calculated from direct measurements of oxygen consumption via respiratory mass spectrometry
研究概览
简要总结
This study will examine the cardiopulmonary interactions that occur with increasing ventilator settings (PEEP and PIP) in neonates after stage I palliation for hypoplastic left heart syndrome before and after sternal closure. Outcome measures include oxygen delivery and cardiac output.
详细描述
The objective of this study is to define the impact of variable levels of PEEP and tidal volume on hemodynamics and lung mechanics around delayed sternal closure after Stage 1 palliation in the single ventricle patient.
The Specific Aims of this work are:
Specific Aim 1: Evaluate hemodynamics and lung mechanics across a range of PEEP (2-12 cm H2O) before and after chest closure, while maintaining consistent ventilation, in infants with single ventricle physiology who undergo delayed sternal closure after Stage 1 palliation surgery.
Specific Aim 2: Evaluate hemodynamics and lung mechanics across a range of tidal volumes (6-15ml/kg) and before and after chest closure, while maintaining consistent ventilation, in infants with single ventricle physiology who undergo delayed sternal closure after Stage 1 palliation surgery.
Hypotheses
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
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
- •All patients who, following stage 1 palliation for single ventricle physiology, undergo delayed sternal closure are eligible to be included in the study
排除标准
- •History of pneumothorax, acute respiratory distress syndrome, or other contraindication to the proposed ventilator manipulations as determined by the responsible CCCU staff physician.
- •Endotracheal tube leak > 15%.
- •Lack of informed consent from parents.
- •Weight less than 2.6kg
结局指标
主要结局
Oxygen Delivery calculated from direct measurements of oxygen consumption via respiratory mass spectrometry
时间窗: Measurements made 15 minutes after each ventilator change. Total duration of observation is 2.5 hours.
Oxygen delivery will be calculated from direct measurements of oxygen consumption via respiratory mass spectrometry and estimates of cardiac output calculated using the Fick equation from measured arterial a venous blood gas samples.
次要结局
- Cardiac Output calculated using the Fick Equation(Measurements made 15 minutes after each ventilator change. Total duration of observation is 2.5 hours.)
研究者
Steven Schwartz
Professor of Paediatrics
The Hospital for Sick Children