A Prospective, Single-Arm, Nonrandomized, Observational Study of Cardiac Output Monitoring in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 3
- 主要终点
- Bias of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
研究概览
简要总结
To assess Cardiac Output Monitoring in pediatric subjects by comparing FloTrac and ClearSight system to intermittent thermodilution Swan-Ganz, in order to expand the indications of FloTrac, ClearSight and Swan-Ganz thermodilution pulmonary artery catheter to the pediatric population 12 to 18 years of age.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are 12 to 18 years of age
- •Subjects who have signed the Informed Consent Form
- •Subjects who are projected to receive Swan-Ganz catheter as part of procedure/standard of care with intermittent cardiac output measures
- •For those Subjects who have had a cardiac transplant,Subjects who are at least 2 weeks post cardiac transplantation
- •Subjects with planned pressure monitoring with an arterial line
排除标准
- •Subjects with contraindications for Pulmonary Artery Catheters Placement and monitoring (recurrent sepsis, or with hypercoagulopathy);
- •Subjects with contraindications for Arterial Line Placement;
- •Subjects with an extreme contraction of the smooth muscle in the arteries and arterioles in the lower arm and hand (i.e., Raynaud's Disease).
- •Subjects with a physical site area too limited for proper Sensor placement
- •Subjects with finger size less than the smallest finger cuff size
- •Documented ≥ moderate pulmonary hypertension (PAPm > 25mmHg, PVRI > 3.0 WUxm2)
- •Presence of intracardiac shunting (i.e., ASD, VSD)
- •Aorto-pulmonary collaterals
- •≥ Moderate tricuspid regurgitation, per echocardiogram criteria
- •> Moderate Aortic or pulmonary regurgitation, per echocardiogram criteria
- •Persistent cardiac arrythmias during the cardiac catheterization period (> 3min)
- •Vascular abnormalities of the arterial system (i.e., connective tissue disorders, mid-aortic syndrome)
结局指标
主要结局
Bias of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
时间窗: Duration of cardiac catheterization procedure, an average of 2 hours
Bias of FloTrac Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis
Precision of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
时间窗: Duration of cardiac catheterization procedure, an average of 2 hours
Precision of FloTrac Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis
Bias of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
时间窗: Duration of cardiac catheterization procedure, an average of 2 hours
Bias of ClearSight Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis
Precision of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
时间窗: Duration of cardiac catheterization procedure, an average of 2 hours
Precision of ClearSight Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis
次要结局
未报告次要终点