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临床试验/NCT02276599
NCT02276599终止不适用

A Prospective Investigation of Pleth Variability Index (PVI) as a Dynamic Parameter of Fluid Responsiveness in Children

Brian Schloss1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
9
试验地点
1
主要终点
Change in Pleth Variability Index

研究概览

简要总结

This study is designed to investigate the ability of pleth variability index (PVI) to non-invasively predict fluid responsiveness in mechanically ventilated children. Patients undergoing atrial septal defect (ASD) repair in the cardiac catheterization suite will be recruited for this study. These patients are ideal candidates because very few deviations will be made from standard clinical practice. All patients will already be under general anesthesia, mechanically ventilated, monitored with pulse oximetry, and provided with intravenous fluid to compensate for their nil per os (NPO) fluid deficit. The only deviation from clinical practice will include an abbreviated echocardiographic exam, application of the Masimo pulse oximeter, and measurement of CO via a thermodilution catheter by the interventional cardiologist.

详细描述

Background: Hypovolemia is a frequent cause of circulatory failure in anesthetized and critically ill children. Fluid boluses are the first line of treatment aimed at optimizing stroke volume and ultimately improving oxygen delivery. A patient whose stroke volume significantly increases as a result of a fluid bolus is deemed 'fluid responsive'. Traditional parameters of circulatory status (e.g. blood pressure, heart rate, central venous pressure) have been shown to be ineffective at predicting fluid responsiveness. Dynamic parameters of fluid responsiveness, such as pulse pressure variation (PPV) and stroke volume variation (SVV), reflect hemodynamic changes secondary to intermittent positive pressure ventilation. These indices have proven to be superior to the traditional static measures of circulatory status in predicting fluid responsiveness. Furthermore, the use of these dynamic parameters in a goal-directed fashion has been shown to improve outcome in high risk, adult surgical patients. As such, there is increasing interest in using dynamic parameters to guide fluid resuscitation in mechanically ventilated infants and children. Unfortunately, there is a paucity of literature examining the validity of these dynamic parameters in children. The need for arterial vascular access, which is less common in small children, has also limited the ability to investigate these parameters. Recently, a non-invasive dynamic parameter has been developed examining the plethysmographic waveform from a pulse oximeter. The pleth variability index (PVI) represents the dynamic changes in hemodynamic performance that occur during the respiratory cycle. Studies of PVI in adults have shown it to be a reliable predictor of fluid responsiveness. However, conclusive data in children are lacking.

Hypothesis

This study is designed to investigate the ability of PVI to non-invasively predict fluid responsiveness in mechanically ventilated children. The hypothesis is that a higher PVI will predict significant stroke volume increases in response to a fluid bolus in mechanically ventilated children.

Methods: The study population will consist of 20 children undergoing cardiac catheterization who will have normal (non-shunted) physiology at the conclusion of the procedure, ages 1-12 years. All subjects will receive a PVI measurement as well as a stroke volume measurement via transthoracic echocardiography. Subsequent volume expansion will be achieved with an intravenous bolus of 10 mL/kg of isotonic crystalloid (normal saline) administered over 10 minutes. After completion of the bolus, an additional PVI measurement and stroke volume measurement will be obtained.

Significance: Hypovolemia is a significant cause of harm in anesthetized and critically ill infants and children. In order to successfully resuscitate these patients, we must gain a better understanding of how to optimize cardiac output and oxygen delivery. A non-invasive monitor which indicates stroke volume responsiveness has the potential to better guide fluid resuscitation and improve outcomes.

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
1 Year 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children undergoing cardiac catheterization who will have normal (non-shunted) physiology at the conclusion of the procedure.

排除标准

  • Patients with additional congenital heart abnormalities, cardiac arrhythmias, ventricular dysfunction, and known pulmonary disease.

结局指标

主要结局

Change in Pleth Variability Index

时间窗: 10 minutes

Change in Pleth Variability Index following fluid bolus of 0.9% normal saline 10 mL/kg over 10 minutes, measured by Masimo Radical-7 monitor.

次要结局

  • Change in Cardiac Output(10 minutes)
  • Change in Stroke Volume(10 mins)

研究者

发起方
Brian Schloss
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Brian Schloss

Assistant Professor

Nationwide Children's Hospital

研究点 (1)

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