July 29, 2002 — Pediatric cardiologists at the University of Utah School of Medicine and Primary Children’s Medical Center (PCMC) will conduct a clinical trial of a blood pressure monitor that may provide an alternative to invasive cardiac catheterization.
The trial, to be conducted with children at PCMC, begins this week and will compare blood pressure readings from cardiac catheterization with those of the Medwave Vasotrac Monitor, said Collin G. Cowley, M.D., principal investigator and assistant professor of pediatrics in the division of pediatric cardiology.
Robert E. Shaddy, M.D., professor of pediatrics and division chief, and Ronald W. Day, M.D., associate professor of pediatrics, are co-investigators in the study.
Cardiac catheterization-in which a catheter is inserted into an artery leading to the heart-is the “gold standard” for accurate blood pressure measurements, Cowley said. But catheterization carries the risks of any invasive procedure, such as infection and bleeding, and many physicians would welcome a reliable alternative for monitoring blood pressure.
Traditional blood pressure cuffs don’t always work with children where small size and activity level often make this method of blood pressure measurement difficult.
The Vasotrac, made by Medwave Inc. of St. Paul, Minn., straps onto the wrist and is about the size of a watch. The device, which comes in portable and stationary models, gives a blood pressure reading every 12 to 15 heartbeats. The Vasotrac works for children age 1 and up.
If the device gives reliable measurements in clinical trials, it may in some instances replace the use of invasive arterial catheters, Cowley said.
The Vasotrac has potential for use on children and adults in emergency rooms and medical clinics outside of hospitals, he said.
The Vasotrac has been on the market for several years and is approved by the U.S. Food and Drug Administration. But until now no clinical trials have been conducted on the device.
Cowley plans to test the Vasotrac on 100 children whose blood pressure is being monitored in PCMC’s cardiac catheterization lab. He’ll compare readings from Vasotrac with those of catheterization. The trial will last about four months.