Impact of Chest Wall Mechanics on Lung and Cardiovascular Function During Delayed Sternal Closure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percentage of patients with successful insertion and measurement of esophageal pressures
研究概览
简要总结
This study aims to describe chest wall mechanics during delayed sternal closure (DSC) in neonates following cardiopulmonary bypass or palliation of congenital heart diseases.
详细描述
This research study is being done so that investigators can understand the complex interactions between the heart, the lungs and the chest wall after heart surgery. Understanding this may guide future care that can help patients with their recovery from heart surgery.
The heart and lungs work together to make sure the body has the oxygen-rich blood it needs to function properly. The chest wall protects the heart, lungs, and other important organs. Investigators would like to learn how a patient's chest wall contributes to the heart and lungs interaction when the chest is left open after heart surgery.
Investigators will be using a device called an esophageal pressure catheter to estimate the pressure that is transmitted to the lungs and heart, called pleural pressure. Previous research has shown that this pressure measurement is used to adjust the breathing machine for patients with lung diseases. Measuring the pressure transmitted to the lungs and heart after heart surgery and delayed chest wall closure may help investigators understand how the chest wall contributes to the heart and lung interaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent provided by parent or primary guardian.
- •Aged <28 days of life at the time of cardiac surgery.
- •Undergone surgery using CPB for congenital heart disease.
- •Undergoing DSC in CCCU.
排除标准
- •Gestational age < 37 weeks or weight < 2 kg at the time of surgery.
- •Endotracheal tube leak >20%.
- •Need of extracorporeal support (ECMO), inhaled nitric oxide.
- •Pre-existing pulmonary disease (For example: Congenital diaphragmatic hernia).
- •Pre-existing or new arrhythmia that can impact hemodynamic assessment.
- •Severe coagulopathy or any other contraindication for the insertion of a nasogastric catheter (e.g., history of tracheo-esophageal fistula).
研究组 & 干预措施
Univentricular physiology
Neonates with univentricular physiology
干预措施: Esophageal manometry catheter at various PEEP levels and tidal volumes (Other)
Biventricular physiology
Neonates with biventricular physiology
干预措施: Esophageal manometry catheter at various PEEP levels and tidal volumes (Other)
结局指标
主要结局
Percentage of patients with successful insertion and measurement of esophageal pressures
时间窗: Immediately prior to chest closure and repeated measurements after chest closure
Investigators hypothesize that successful esophageal catheter placement and measurement of Pes (full data set) will occur in ≥80% of enrolled subjects.
次要结局
- Length of Hospital Stay(At 30 days post-operation or discharge (whichever comes first))
- End-inspiratory and end-expiratory transpulmonary pressure(Prior to and immediately after sternal chest wall closure procedure)
- Transmural diastolic pressures(Prior to and immediately after sternal chest wall closure procedure)
- Chest wall and lung compliance(Prior to and immediately after sternal chest wall closure procedure)
- Changes in transmural pressures(Prior to and immediately after sternal chest wall closure procedure)
- Duration of inotropic support(At 30 days post-operation or discharge (whichever comes first))
- Mortality(At 30 days post-operation or discharge (whichever comes first))
- Length ICU Stay(At 30 days post-operation or discharge (whichever comes first))
- Duration of mechanical ventilation(At 30 days post-operation or discharge (whichever comes first))
- Transmural systolic pressures(Prior to and immediately after sternal chest wall closure procedure)
- Duration of support with supplemental oxygen(At 30 days post-operation or discharge (whichever comes first))
研究者
Luciana Rodriguez Guerineau
Staff Physician
The Hospital for Sick Children