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

Stopped early

Conditions studied: Atrial Septal Defect

In brief

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.

Key facts

Study ID

NCT02276599

Run by

Brian Schloss

People needed

9

Starts

2015-02-01

Expected to finish

2018-05-31

Last updated by the study team

2018-10-18

Who can join

Age: 1 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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