CONTINUOUS INTRAPARTUM FETAL PH, PO2, PCO2, TEMPERATURE, ANDECG

INTERNATIONAL BIOMEDICS, INC. WILL DEVELOP AND PROVE A FETAL SPIRAL SCALP PROBE FOR CONTINUOUS INTRAPARTUM MONITORING (CIM) OF ECG, PH, PO2, PCO2, AND TEMPERATURE. THIS WILL PROVIDE LABILE FETAL DATA (ECG, BLOOD GASES) AND OTHER DATA REFLECTING THE TOTALITY OF RECENT METABOLIC INSULTS (PH, TEMPERATURE). THE UTILITY OF CIM OF FETAL ECG AND PH SAMPLING IS WELL KNOWN. THE LITERATURE INDICATES THAT THE CIM OF PO2, PCO2, AND FETAL-MATERNAL TEMPERATURES MAY BE OF VALUE, AND IT IS BELIEVED THAT THEY CAN BE USED TO DETECT IMPROPER PROBE PLACEMENT. THE COMPLETE CIM DATA SHOULD ENHANCE THE RELIABILITY OF FETAL DIAGNOSIS AND THERAPY. INTERNATIONAL BIOMEDICS, INC HAS DEVELOPED AND EVALUATED A CIM SPIRAL ECG/TISSUE PH PROBE IN A 300-PATIENT, INVESTIGATIONAL DEVICE EXEMPTION (IDE) CONTROLLED STUDY FOR THE FOOD AND DRUG ADMINISTRATION. IN ADDITION, A 430-MICRON-DIAMETER, MULTIPARAMETER (MP) INTRAVASCULAR PROBE FOR PO2, PCO2, PH, AND TEMPERATURE IS BEING TESTED. DURING PHASE I, THE MP SYSTEM WILL BE ADAPTED TO THE NEEDS OF CIM, AND THE BENCH, TOXICOLOGY, AND INSTRUMENT QUALIFICATION STUDIES WILL BE COMPLETED. DURING PHASE II, ASUBCUTANEOUS POUCH AND FETAL ANIMAL STUDIES WILL BE PERFORMED IN PIGS TO QUANTIFY THE SUBCUTANEOUS PROBE DATA VERSUS ARTERIAL AND VENOUS DATA. LATER IN PHASE II, IDE-CONTROLLED CLINICAL TRIALS OF SAFETY, EFFECTIVENESS, AND CLINICAL SIGNIFICANCE WILL OCCUR. INNOVATIONS IN DEVELOPMENT ARE A SPIRAL, APPLICATOR-TOOL, PRECALIBRATED CLOSED STERILE PROBE TO MEASURE THE RELATION OF TISSUE DATA TO BLOOD DATA, AND MEANINGFUL DISPLAY METHODS (HUMAN FACTORS).