Hemodynamic Assessment of the Right Ventricle Using Pressure-volume Loop Catheter and Pulmonary Artery Catheter in Patients Undergoing Left Ventricular Assist Device Placement at the University of Minnesota Medical Center
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- End-diastolic pressure
研究概览
简要总结
This study will include the placement of a pressure volume (PV) loop catheter in the right atrium of patients undergoing left ventricular assist device (LVAD) placement and measure relevant PV loop data. Transesophageal echocardiography (TEE) and pulmonary artery (PA) catheter parameters as comparators to the PV loop will be recorded.
详细描述
This will be a prospective observational study design to characterize right ventricular function in 5 consecutive patients undergoing LVAD implantation at the University of Minnesota Medical Center (UMMC). Pre-, intra- and postoperative care delivery to all enrolled and consented patients will meet the standards of care otherwise delivered to patients undergoing LVAD implantation at UMMC; care delivery will be at the discretion of the clinical care team and will not be altered based on the output of the right ventricular high-fidelity conductance catheters.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing left ventricular assist device (LVAD) placement at the University of Minnesota Medical Center
排除标准
- •Patients with a history of internal jugular vein thrombosis or known reasons for not being able to thread a central venous catheter through either internal jugular vein
- •Patients with a history of known esophageal strictures, esophageal or stomach cancer, esophageal varices, or any patient in whom a TEE is contraindicated
- •Patients with permanent pacemakers whose right ventricle is being paced and not in normal sinus rhythm
- •Patients unable to consent to participating in the study
- •Patients who are pregnant will be excluded, as part of standard care, all female patients are screened for pregnancy prior to surgery.
结局指标
主要结局
End-diastolic pressure
时间窗: Approximately 4-6 hours
End-diastolic pressure will be reported in units of mmHG
End-diastolic volume
时间窗: Approximately 4-6 hours
End-diastolic volume will be reported in units of milliliters
Stroke work
时间窗: Approximately 4-6 hours
Stroke work will be reported in units of gram meters (g\*m)
Stroke volume
时间窗: Approximately 4-6 hours
Stroke volume will be reported in units of millilitres per square metre
End-systolic pressure
时间窗: Approximately 4-6 hours
End-systolic pressure will be reported in units of mmHG
End-systolic volume
时间窗: Approximately 4-6 hours
End-systolic volume will be reported in units of milliliters
Heart rate
时间窗: Approximately 4-6 hours
Heart rate will be reported in units of beats per minute
Ejection fraction
时间窗: Approximately 4-6 hours
Ejection fraction will be reported as a percent
Cardiac output
时间窗: Approximately 4-6 hours
Cardiac output will be reported in units of milliliters per minute
Right ventricular dP/dt
时间窗: Approximately 4-6 hours
Right ventricular dP/dt will be reported in units of mmHg per second
次要结局
未报告次要终点