Early Feasibility Study of an Electronically Controlled Gravity Feed Infusion Set for intravenous Fluids in Adults

Abstract

A first in human single arm clinical study was conducted to determine the utility and safety of an Electroni-cally controlled gravity feed (ECGF) infusion set, a low cost gravity feed infusion controller designed to improve intrave-nous administration of fluids and medication in resource con-strained settings. The primary objective of this study was to estimate the accuracy and safety of the ECGF device in deliv-ering a constant flow rate for therapies between 5 -100 drops/min in a sample adult population. 12 participants with an indication for intravenous fluid therapy that met the inclusion criteria and provided written informed consent were enrolled from the infectious diseases ward at Mulago National Referral Hospital, Kampala, Uganda and were all placed on the ECGF device for one infusion ther-apy. Patient physiological parameters were recorded over a period of 48hours. Maximum and minimum percentage varia-tions Ep (max) and Ep (min) for analysis periods T1 (second hour) and T2 (last hour) showed a percentage error within ±7% for all 12 patients. Physiological parameters for study participants over the 48 hour period were stable as would be expected from a correct infusion therapy. The ECGF device was able to maintain flow rates within acceptable error during intravenous therapy and provide an appropriate level of safety for adult patients owing to its sensi-tivity in sounding alarms in the event of flow rate deviations. The ECGF has shown potential in improving the standard of care for intravenous therapy in resource limited settings.