Evaluation of the Efficacy and Safety of Griflow® Dual, a Pre-Set Two-Flow Infusion Device for Intravenous Immunoglobulin (Flebogamma® 5%) Administration

Abstract

Purpose A single center, prospective study was performed to assess the efficacy and safety of Griflow® Dual–-a gravity-fed device for intravenous delivery of human immunoglobulin Flebogamma®. Methods A total of 2 infusions in 2 visits per patient were assessed using G2 and G3 Griflow® Dual models that provide different flow rates adjusted to the patient's weight. To follow the most common method of intravenous immunoglobulin administration, infusion through the two-way device commenced with the low flow rate capillary (clamp closed) for 30 minutes and continued with the high flow rate, opening both ways. Reliability of flow delivery (average flow rates), adverse events, as well as functionality in daily practice (questionnaire to nurses) were assessed. Results twenty-five valid infusions were evaluated on 13 subjects. Except for the G2 model with closed clamp in which 14.5% deviation was observed, actual average flow rate values fell well into the maximum 10% deviation permitted with respect to expected charted values (G2: 55 and 142 mL/h; G3: 76 and 189 mL/h). Discrepancies could be explained by patient's arm movements or posture change during infusion. No adverse events related to the study device occurred. In the functionality questionnaires, nurse's comfort and safety of infusion with Griflow® Dual were rated higher than without Griflow® Dual but lower than with infusion pumps. Conclusions Although it may not be as precise as an infusion pump, Griflow® Dual proved to be a reliable and suitable device to administer Flebogamma® 5%. Correct safety should be confirmed in a larger sample.