News | December 05, 2007

First Clinical Study Published on Critical Care Oximetry Device for Children

December 6, 2007 - Earlier this year Edwards launched PediaSat, a critical care monitoring product for children, and this week the first published clinical study validated its efficacy over other methods in monitoring life-threatening conditions in children (infants to age 16) who undergo cardiac surgery.

With the new supporting clinical evidence, the company hopes PediaSatis becomes a best practice for monitoring pediatric conditions in the OR and ICU. The study “An Experimental and Clinical Evaluation of a Novel Central Venous Catheter with Integrated Oximetry for Pediatric Patients Undergoing Cardiac Surgery” was conducted by Oliver J. Liakopoulos, M.D.; Jonathan K. Ho, M.D.; Aaron Yezbick, M.D.; Elizabeth Sanchez, BS; Clayton Naddell, BS; Gerald D. Buckberg, M.D.; Ryan Crowley, M.D.; and Aman Mahajan, M.D., Ph.D.

Central venous oxygen saturation (ScvO2) accurately reflects cardiocirculatory function, but is not always feasible in pediatric patients. Using an experimental and clinical approach, the authors determined the accuracy of Edward’s pediatric central venous catheter with integrated fiberoptic oximetry, correlated ScvO2 to periprocedural vital variables.

The study used five anesthetized pigs using hemodynamics and compared the fiberoptic ScvO2 catheter to standard blood gas oximetry through blood analysis. The tests were conducted during stable baseline conditions, preload reduction (caval occlusion), and dopamine. In 16 pediatric patients undergoing cardiac surgery (median age 8.4 months, weight 8.0 kg), central venous oximetry catheters were placed percutaneously, and ScvO2-cath and hemodynamics recorded at several time-points during and until 24 hours after surgery. Oximetry and hemodynamic data were then compared by correlation and the Bland–Altman analysis.

The results were no catheter-related complications and ScvO2-cath and ScvO2-blood measurements correlated significantly. The authors concluded integrated central venous oximetry catheters provide accurate continuous ScvO2 monitoring in pediatric patients undergoing cardiac surgery. They also found ScvO2 fiberoptic oximetry correlates better with changes in CI as compared to routine hemodynamic variables.

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