NONINVASIVE BLOOD-GAS MONITOR FOR INFANTS TO ADULTS

PHASE I RESEARCH WILL EVALUATE AND DEMONSTRATE THE FEASIBILITY OF MAKING ACCURATE NONINVASIVE AND CONTINUOUS MEASUREMENTS OF ARTERIAL BLOOD GASES (PO2, PCO2, AND PH) IN A SINGLE DEVICE, UTILIZING THE ORAL MUCOSA AS A UNIQUE AND OPTIMAL SITE FOR THESE MEASUREMENTS. INNOVATIVE SENSOR FEATURES WILL BE EVALUATED IN VITRO AND WITH HUMAN VOLUNTEERS. ADVANCED TECHNOLOGY PREVIOUSLY DEVELOPED FOR THE ORAL MEASUREMENT OF PO2 WILL BE APPLIED TO MODIFY PRESENTLY AVAILABLE PCO2 AND PH SENSORS TO PERMIT ORAL USE AND ACHIEVE HIGH ACCURACY OF ARTERIAL BLOOD GAS MEASUREMENTS. A MINIATURIZED SENSOR MODULE CONTAINING SENSORS FOR ALL THREE BLOOD GASES WILL BE DESIGNED INCORPORATING THIS TECHNOLOGY, AND IT WILL FIT EASILY AND UNOBTRUSIVELY INTO THE MOUTH. THIS SENSOR MODULE AND ITS ASSOCIATED ELECTRONICS WILL PROVIDE CAPABILITIES AND CLINICAL ADVANTAGES NOT FOUND IN ANY OTHER DEVICES; IN PARTICULAR, MEASUREMENT ACCURACIES THAT ESSENTIALLY EQUAL THOSE OF BLOOD GAS MACHINES ARE ANTICIPATED. THE RESEARCH WILL DEFINE THESE CLINICAL ADVANTAGES, ALONG WITH THE SUITABILITY OF THIS CONCEPT FOR VARIOUS PATIENT TYPES AND CLINICAL USES. THIS SYSTEM IS EXPECTED TO BE EQUALLY APPLICABLE TO INFANT, PEDIATRIC, ADULT, AND AGED PATIENTS.