跳至主要内容
临床试验/NCT03921164
NCT03921164已完成不适用

Non Invasive Pressure -Volume Loop (PVLOOP) With 3D Echocardiography and Arterial Tonometry

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2021年1月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Aortic pressure in the descending thoracic aorta in mmHg (PAo)

研究概览

简要总结

In patients under general anesthesia, the prevention of intraoperative hypotension to maintain blood pressure (BP) close to the initial blood pressure, i.e. before anesthesia, is essential to reduce the risk of death and improve surgical outcomes. Vasoactive agents are commonly used to correct this hypotension (Phenylephrine Ephedrine Noradrenaline). These three vasoconstrictors have specific effects on the afterload of the heart and can impair its function. The analysis of the left ventricular pressure-volume curve (PV Loop) allows continuous information on the post-charge state of the left ventricle and the changes induced by the vasoconstrictors to be observed. However, the investigators currently have no way of monitoring these effects. In clinical practice if these loops are obtained non-invasively they can be used in the evaluation of cardiac function of at-risk patients in perioperative and also in intensive care to allow therapeutic adaptation.

详细描述

Investigators have conducted several studies on the differential effects of different vasopressors used in general anesthesia to correct sympatholysis-induced hypotension occurring under anesthetic drugs and after eliminating hypovolemia or overdose in anesthetics.

In a pilot study investigators described a method for analyzing Velocity-Pressure interactions to monitor ventricular afterload in the operating room with the construction of Velocity-Pressure aortic loops (VP Loop).

These loops were constructed from an aortic velocity signal measured by esophageal Doppler and aortic blood pressure signal from a femoral catheter. The Global Afterload Angle (GALA) measured on the loop were then higher in patients at cardiovascular risk (RCV+) at 68 ± 6° compared to 41 ± 15° in patients (RCV-) (p<0.001). In addition, GALA variations were associated with variations in the three components of ventricular afterload: compliance, resistance and waves reflection. Finally, under the effect of vasopressors, there was a modification in the shape of the VP Loop and the value of GALA, showing GALA as a reliable marker potential for ventricular afterload in patients under general anesthesia.

In order to develop a totally non-invasive method that would produce a pressure velocity curve, the investigators propose to combine an estimation of aortic pressure by a tonometry method and an estimation of ventricular volumes by three-dimensional echocardiography.

The main objective of this study is then to compare VP Loop parameters obtained non-invasively to VP loop obtained invasively according to patient cardiovascular risk factors.

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • Patients > 18 years, scheduled for an elective interventional neuroradiology procedure under general anesthesia requiring a continuous monitoring of mean arterial pressure and cardiac output.

排除标准

  • age <18 years
  • Patient who has not signed the consent
  • Pregnant woman
  • Patient under judicial protection
  • Patient without affiliation to a social security scheme

结局指标

主要结局

Aortic pressure in the descending thoracic aorta in mmHg (PAo)

时间窗: Duration of the interventional neuroradiology procedure (maximum 1 day)

For all patients, aortic pressure will be collected at the end of the procedure during catheter withdrawal

Aortic velocity in the descending aorta in cm/s (VAdes.)

时间窗: Duration of the interventional neuroradiology procedure (maximum 1 day)

For all patients, aortic descending velocity will be collected at the end of the procedure during catheter withdrawal.

Central pressure by tonometry (CP in mmHg)

时间窗: Duration of the interventional neuroradiology procedure (maximum 1 day)

For all patients, central pressure by tonometry will be collected at the end of the procedure.

Ventricular diastolic pressure (VdP in mmHg)

时间窗: Duration of the interventional neuroradiology procedure (maximum 1 day)

For all patients, ventricular diastolic pressure by 3D echocardiography will be collected at the end of the procedure.

Left ventricular volume (LVV in mL)

时间窗: Duration of the interventional neuroradiology procedure (maximum 1 day)

For all patients, left ventricular volume by 3D echocardiography will be collected at the end of the procedure.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Non Invasive Use of Pressure-Volume Loop in the... | 临床试验