Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Hemodynamics as characterized by change in pulmonary blood flow
研究概览
简要总结
The purpose of this study is to assess for acute hemodynamic changes after implementation of noninvasive negative pressure ventilation (as compared with spontaneous respiration) in pediatric patients with Fontan failure using modern negative pressure ventilators
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Fontan physiology with clinical evidence of Fontan failure as defined by those with one of the following in addition to Fontan circulation: New York Heart Association Class II, fluid retention, cyanosis, protein losing enteropathy, renal/hepatic dysfunction and/or subjectively qualify for hemodynamic assessment (by primary cardiologist).
排除标准
- •Patients which will likely require intubation for catheterization
- •Severely depressed systemic ventricular systolic function
- •Baseline airway obstruction
- •Plastic bronchitis
- •Significant OUTFLOW obstruction
研究组 & 干预措施
Hayek RTX ventilator
Participants will receive noninvasive negative pressure ventilation.
干预措施: Hayek RTX ventilator (Device)
结局指标
主要结局
Hemodynamics as characterized by change in pulmonary blood flow
时间窗: Baseline, 45 Minutes
Change in pulmonary blood flow will be measured at baseline and completion of noninvasive negative pressure ventilation.
Hemodynamics as characterized by change in cardiac output
时间窗: Baseline, 45 Minutes
Cardiac output will be measured in liters per minute at baseline and completion of noninvasive negative pressure ventilation
Hemodynamics as characterized by change in pulmonary artery pressure
时间窗: Baseline, 45 Minutes
Pulmonary artery wedge pressure will be measured in millimeters of mercury (mmHg) at baseline and completion of noninvasive negative pressure ventilation.
Hemodynamics as characterized by change in systemic arterial saturation
时间窗: Baseline, 45 Minutes
Systemic arterial saturation measures the amount of oxygen in the blood stream. Systemic arterial saturation will be registered at baseline and completion of noninvasive negative pressure ventilation.
次要结局
未报告次要终点
研究者
David Peng
Assistant Professor of Pediatrics and Communicable Diseases
University of Michigan