NCT01662011Unknown3 期
Application of Neurally Adjusted Ventilatory Assist to Children After Congenital Cardiac Surgery: the Effect of Patient-ventilator Interaction, Gas Exchange and Hemodynamics
Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2010年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Asynchrony index and Comfort Scale
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. It was a controlled randomized single-center prospective study in order to explore the efficacy of this new mode of mechanical ventilation after corrective open-heart surgery for congenital heart disease.
详细描述
- To evaluate the effect of the patient-ventilator interaction in children underwent open-heart surgery when ventilated with NAVA, compared with conventional mechanical ventilation.
- To verify the benefits of NAVA in improving the gas exchange and hemodynamics after biventricle repair for CHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients underwent cardiac surgery with biventricle repaired
- •patients need mechanical ventilation more than 24hrs after cardiac surgery
排除标准
- •age >18 years
- •inappositely of catheter insertion
- •hemodynamic instability
- •coagulation disorders or bleeding
- •inclusion in other research protocol
结局指标
主要结局
Asynchrony index and Comfort Scale
时间窗: 2 weeks
次要结局
- Dosage of sedatives(2 weeks)
- hemodynamics(2 weeks)
- Duration of mechanical ventilation(2 weeks)
- Gas exchange(2 weeks)
- Length of ICU stay(2 weeks)
研究者
Limin Zhu
Attendant doctor, Department of thoracic and cardiovascular surgery
Shanghai Jiao Tong University School of Medicine
研究点 (1)
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