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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:

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
Sponsor: Brian Schloss

Current Primary Outcome: Change in Pleth Variability Index [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Cardiac Output [ Time Frame: 10 minutes ]
    Change in cardiac output following fluid bolus of 0.9% normal saline 10 mL/kg over 10 minutes, measured by interventional radiologist during cardiac catheterization.
  • Change in Stroke Volume [ Time Frame: 10 mins ]
    Change in stroke volume following fluid bolus of 0.9% normal saline 10 mL/kg over 10 minutes, measured by echocardiogram.


Original Secondary Outcome: Same as current

Information By: Nationwide Children's Hospital

Dates:
Date Received: October 23, 2014
Date Started: February 2015
Date Completion: December 2017
Last Updated: October 10, 2016
Last Verified: October 2016