Intravenous fluid therapy: a randomized controlled trial to investigate the effectiveness of the IV2TM flow medical device

Objectives.  To investigate the hypothetical benefits of the IV2TM flow medical device. Background.  Intravenous fluid administration is a standard hospital procedure with assumed inadequacies. The IV-Event Study [Fraser N, Nel G, Snyman J & Wessels F (2004) IV-EVENT Study: Intravenous Infusion Therapy – Management and Adverse Events. Data on File: Varori International (Pty) Ltd., Centurion, South Africa] quantified these inadequacies; The ‘Stargait’ intervention trial investigated the effectiveness and possible cost-benefit of the IV2TM flow. The IV2TM flow is intended for routine use with gravitational intravenous infusion sets. The IV2TM flow should reduce the incidence rate of adverse events and maintain a set flow rate. Method.  Nursing staff assisted by study assessors captured relevant data. Consented patients were enrolled for the period of their prescribed infusions. Intervention.  The Stargait Trial compared the treatment group (standard gravitational sets with the IV2TM flow) with the control group (standard gravitational infusion sets without IV2TM flow). The difference in observed events and the cost benefit derived from this were measured. Results.  A total of 2387 drip hours were observed in 52 patients. The adverse event rates were: Control group (without IV2TM flow) 33·8%. The treatment group (IV2TM flow) 15·4%. This 55% reduction is statistically significant (p = 0·0069). Adverse event related monetary wastage (labour and consumables) is reduced by 76% for infusion bags in the intervention group (with IV2TM flow). There was a significant difference between the treatment group and control group as far as deviation in flow rate was concerned (p = 0·00818). The mean deviation of the IV2TM flow group was just more than 5 ml per hour. The standard line group had a mean deviation of more than 30 ml per hour. Conclusion.  Gravitational intravenous therapy compromises quality of patient care. The Stargait Trial has proven the care-effectiveness and cost-effectiveness of the IV2TM flow. Relevance to clinical practice.  The IV2TM flow improves quality of patient care and reduces associated wastage.