A Novel, Low-Cost Device to Guide Peripherally Inserted Central Catheter (PICC) Line Placement in Pediatric and Neonatal Patients

Abstract Improper placement of peripherally inserted central cathetersPICCscan be life threatening to pediatric and neonatal patientsPICCs are widely used in pediatrics to provide life sustaining intravenous therapieswhere navigation through the venous system is typically performed blindor without image guidanceAs a resultup toof pediatric placed PICCs are improperly positioned into the right atrium and require repositioningthe placement of a catheter tip into the heart is associated with a multitude of life threatening complications such as atrial arrhythmiaheart valve damagecatheter related right atrial thrombiand myocardial perforation leading to pericardial effusionThe prevalence of pericardial effusion and consequent cardiac tamponade in neonates with a PICC line placement iswithmortalityAdditionallyof PICCs placed into the pediatric population are improperly navigated through the venous systemrequiring removal and reinsertionThese complications carry physical and emotional burdens to children and their familiesDespite serious adverse events associated with blind placement of PICC linesguidance systems are not available for neonatal and pediatric patientsThe Teleflex ARROWGVPS and the Bard SherlockCGare effective for navigation and placement of a catheter tip into the SVC or CAJ inof patientshoweverthey require the use of catheters that are too large for childrenTo address the need for accurate and safe vascular access in young patientsTheraNova has developed PICCOLOan easily operatedpoint of care thermodilution catheter system scaled for real time vascular access guidance in childrenWe have designed PICCOLO with the following key innovationsProprietary thermodilution catheter system provides real time hemodynamic data for identification of key vascular landmarksScalable for use in neonatal and pediatric patientsandCost effective and easyto use for widespread clinical adoptionPreviouslywe found that the unique thermodilution signatures of five anatomical locations could be successfully distinguished in vivo with our PICCOLO prototypeFurtherwe have developed a refined prototypescaled to the dimensions required for use in neonatesthat can identify the SVC from vascular regions that are considered improper and dangerous for placement of PICC tipsThe goals of this Phase I proposal are to optimize the system and determine the thermodilution signatures of distinct vascular regions in a weanling pig modelFirstwe will optimize the signal resolution of the PICCOLO prototype by evaluating saline infusion parameters over varying pulsatile venous flow conditions in a benchtop cardiovascular modelSpecific AimSecondwe will compare the thermodilution profiles for PICC tip placement in several key vascular locations as compared to the CAJ in five weanling pigsSpecific AimThe proof of concept data obtained through this proposal will demonstrate the use of thermodilution to provide accurate vascular accessThese data will also be used to support a Phase II submissionwhich will include preclinical and clinical studies to validate placement accuracy in neonatal and pediatric patients Narrative Peripherally inserted central cathetersPICCsare widely used in children to provide life sustaining intravenous therapieswhere navigation through the venous system is typically performed blindor without navigation guidanceCommercially available real time vascular access systems can be effectivebut are not available for use in childrenWe propose an inexpensiveeasily operatedpoint of care thermodilution catheter system scaled for real time vascular access guidance in children