Clinical Performance Evaluation of Pediatric and Neonatal Low Saturation Oximetry Sensors

1.0 BACKGROUND

A common method for assessing the respiratory status of hospitalized pediatric and neonatal patients is the use of pulse oximetry. This noninvasive device uses a light emitting diode (LED) emitter, which is applied to an area of the body with good local blood flow. Red and infrared light is shined through the blood-perfused tissue under the sensor and the detected light information is sent back to a signal processing unit, or monitor, for calculation of oxygen saturation (SpO2)1. Typically the sensor may be placed either on the forehead, a finger, or in neonates - the foot, palm or toe. Use of this noninvasive method provides continuous information on the oxygenation status of patients and has greatly reduced the number of arterial blood gas punctures or samples required for patient care.

While the advantages of noninvasive pulse oximetry are significant, there are a number of factors that can negatively impact the performance of the device2. Patient monitoring during low saturation episodes has been one of the challenges to optimal device performance. Improvements to sensor technology over the last 20 years have progressively improved the accuracy and reliability of the device. Since their introduction to clinical care in the 1980's, a number of improvements have been made to increase the accuracy of pulse oximetry in oxygen saturations of 80% and below.

Nonetheless, while much of the clinical research on pulse oximetry sensors over the years has evaluated device accuracy and reliability, limited data are available in these conditions1,6.

The purpose of this study is to evaluate the accuracy of new pulse oximetry sensors specifically designed for low saturation episodes in pediatric and neonatal patients. Results of this study will provide basic information to drive further improvements in the technology.