Cardiopulmonary Effect of Mechanical Ventilation in Children Underwent Surgical Repair of Right Ventricular Hypertrophy: Compared With Pressure Control Ventilation, Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Cardiac output index
研究概览
简要总结
Neurally adjusted ventilatory assist (NAVA) is a new mode of mechanical ventilation that delivers ventilatory assist in proportion to neural effort. The investigators hope to compare the hemodynamic and pulmonary effect in children after surgical repair of congenital heart disease with right ventricular hypertrophic ventilated with Pressure control ventilation (PCV), Pressure support ventilation (PSV), and NAVA by a crossover study.
详细描述
In the patients suffered from congenital heart disease with right ventricular hypertrophy, the preload of the heart will be influenced by the variation of the intrathoracic pressure. The cardiopulmonary interaction during mechanical ventilation will be an important influence factor on hemodynamics after surgical repair for these patients. As a new mode of mechanical ventilation, NAVA delivers ventilatory assist in proportion to patients' neural effort avoiding over ventilation.
The investigators designed a crossover study to evaluate the cardiopulmonary effect in patients with congenital heart disease with right ventricular hypertrophy when ventilated with NAVA postoperatively, compared with the conventional mode of pressure control ventilation and pressure support ventilation. Each patient will undergo three 60-min trials during the study period in randomized order. The cardiac output and volume status will be evaluated by a transpulmonary thermodilution device through a pulse contour cardiac output (PiCCO) catheter at the last 10min of each trial. At the mean while an arterial blood gas and echocardiography will perform.
Data are expressed as mean ± standard deviation. Datas from the three registrations will be compared using a repeated-measures ANOVA. The comparison of each mode will be assessed by the SNK methods post hoc test. A p value of less than 0.05 was considered significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 3 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients underwent surgical repair of right ventricular hypertrophic congenital heart disease
- •Obtain informed consent signed by parents
排除标准
- •Significant residual shunt (more than 2mm), residual obstruction of right ventricular outflow tract (RVOT) or A-V valve insufficiency.
- •Hemodynamic instability (whose inotropic score more than 20);
- •Significant bleed (whose chest drainage more than 5ml/kg/h);
- •Failed to insert the PiCCO catheter
- •Dysfunction and abnormal of esophage;
- •Inclusion in other research protocol
结局指标
主要结局
Cardiac output index
时间窗: Within 72 hours after opeartion
Cardiac output index messured by PiCCO and echocariography should be improved when ventilated with NAVA or PSV compared with PCV.
次要结局
- Mean airway pressure(Within 72 hours after opeartion)
- Arterial partial pressure of oxygen(Within 72 hours after opeartion)
- Peak inspiratory pressure(Within 72 hours after opeartion)
- ScvO2(Within 72 hours after opeartion)
- Arterial partial pressure of carbon dioxide(Within 72 hours after opeartion)
- Arterial oxygen saturation(Within 72 hours after opeartion)
- Lactate(Within 72 hours after opeartion)
- Urine output(Within 72 hours after opeartion)
研究者
Limin Zhu
Deputy chief physician
Shanghai Jiao Tong University School of Medicine