In ICUs and Operating Rooms, pediatric patients are often exposed to painful procedures such as arterial catheters and placement of multiple wires and electrodes on delicate skin in order to monitor critical vital signs. About one third of all patients in ICUs (including children and adolescents) endure an invasive arterial catheter (“A-Line” or “Art-Line”) for continuous “beat by beat” BP. The other two-thirds are monitored using automatic “arm squeeze” sphygmomanometers, which are programmed to inflate every 30 or 60 minutes, often waking the patient with discomfort. Continuous BP measurements provide a much better indication of patient health than “spot check” arm cuffs, allowing clinicians to observe sudden falls or rises in blood pressure that might not otherwise be noticed between automated cuff inflations, especially during anesthesia, recovery, and critical care events. The invasive A-Line typically used to obtain Continuous BP is particularly challenging in pediatric patients due to small cannula, as well as infection risk, patient pain, and enablement with other monitoring wires on small bodies. Juvenile dialysis patients would also benefit from continuous BP measurements instead of intermittent ‘spot-check’ BP from upper arm cuff inflations to provide clinicians with early indications of health deterioration.
Many other procedures, including most inpatient or outpatient surgeries, would benefit from Continuous BP, especially to inform finer adjustments in anesthesia and fewer excursions into hypotension. Our CareTaker4 Continuous Non-Invasive Blood Pressure (“CNIBP”) and wireless vital signs monitor has been clinically proven and FDA-cleared to provide Continuous BP with A-Line accuracy and Heart Rate with ECG accuracy, but uses only a comfortable low-pressure finger cuff instead of invasive catheters and ECG electrodes. By wirelessly displaying real time data and waveforms on iPads and other displays without wired encumbrances, doctors can observe hemodynamic trends such as arrhythmias, hypotensive events, or hypervolemia, directly through the pulse wave form without electrodes. In the case of pediatric dialysis or infusions, CareTaker’s ability to measure continuous blood volume along with BP provides clinicians with a real time view of patient hemodynamic health without additional wires and hoses constraining the patient. In short, CareTaker can provide a wireless, non-invasive, pain-free alternative to pediatric CNIBP and Vial Sign monitoring without the myriad of wires and hoses tethering small bodies to large monitoring equipment that restrict movement, interfere with clinical treatment, or prohibit a comforting hug from a parent.
The CareTaker4 pediatric device is a simple, low-pressure finger cuff that measures CNIBP, Heart Rate, Respiration rate, SpO2, Blood Volume, and other hemodynamic parameters displayed in a wireless remote monitor. Caretaker4 has wireless Bluetooth capabilities, which acts as a wearable medical hub, while collecting data and reporting the data into a Tablet App or integrating the data into an Electronic Medical Record. The device focuses on the miniaturization of the finger cuff and wrist unit to accommodate pediatric anatomy, and to conduct pediatric patient studies to develop the Pulse Wave Analysis algorithm changes needed to address the shorter arterial tree of children.
APDC will help to design a smaller form factor finger cuff, prototype manufacturing of pediatric cuff designs, and define algorithm refinements and pediatric advisor guidance.