Innovative Health Sciences presented a case study using the Inisgnis™ Syringe Infusion System at the 2022 IPIC Congress in Vilamoura, Portugal. Click the link below to learn more about the successful case study using the OneSett™ Subcutaneous Administration Set.
Ideally, every Subcutaneous Immunoglobulin (SCIg) patient deserves a pain free infusion every time an administration is performed. This has been difficult to ensure until the development of a novel infusion system to facilitate monitoring and modifying the ﬂow rate during the actual Infusion. This system can determine the patency of the sites for each infusion and enables real-time ﬂow rate adjustment. The reactions patient have complained of can be minimized or stopped before they start. The objective of this case study was to conﬁrm the theoretical prediction that such a system could perform in the clinical environment, creating a breakthrough for patients who infuse subcutaneous immunoglobulin.
After setting the OneSett™, the patient noted the volume in the syringe, and a stopwatch was started. The remaining volume was noted after 10 and 20 minutes consecutively. Actual ﬂow rates were calculated to be 67ml/hr after 10m and 50ml/hr after 20ml, showing a decreased speed. Since the system is sensitive to differential pressure (termed “Dynamic Equilibrium”), a detectable decrease indicated that the initial ﬂow rate was creating tension from the added ﬂuid in the subcutaneous space. After infusing 35ml, the ﬂow rate was manually decreased to 25ml/hr and continued to the end with no further impairment of ﬂow rate or evidence of tissue saturation.
Total time of infusion for 50ml was 24:26 minutes. The patient commented that he could “feel” improvement in the reduced ﬂow rate. At the end of the infusion, when the needles were removed, there was no redness, pain, leaking or any site sequalae.
Theory has long predicted that subcutaneous immunoglobulin administrations can begin at the highest ﬂow rate – but may need to be decreased during the procedure to prevent site reactions. This is caused by beginning with empty depots in the subcutaneous space which under high ﬂow rates may quickly ﬁll with drug- decreasing tissue perfusion. To deliver the fastest ﬂow rates possible and therefore the minimum time of infusion, the objective is to begin the infusion at the highest rate and then manually decrease it as the sites begin to ﬁll or saturate. This new approach has the capability to revolutionize SCIg administrations providing infusions in minimal time with little or no adverse site reactions.
An experienced SCIg patient was selected to deliver 50ml using the OneSett™ (three 26G needles) and a 13.5psi mechanical syringe infusion driver. The infusion began at the highest ﬂow rate and was monitored during the procedure. If any decrease in rate was noted, the setting was manually reduced. An assessment of the sites was completed immediately after the infusion.