Comparing economic benefits for patients using active V.S. passive warming system undergoing major surgeries: a protocol of randomized controlled trial

Background: Incidence rate of intra-operative hypothermia during surgeries is estimated to be around 40% in China, causing damages as cardiovascular complications and also increase costs due to treatment for adverse reactions and prolonged hospital stay. However in current stage, hypothermia and effective warming measurements are attached with relatively low importance in aesthesia procedures. This study aims to compare the potential economic benefits for patients using active warming system during major surgeries. Methods: A randomized controlled open-label trial was design in Beijing, China. Target population were patients undergoing surgeries. A total of 240 patients receiving Pancreatectomy and Esophagectomy were randomized into active warming group (using forced air warming system) and passive warming group (using cotton blanket). Health outcomes as incidence of intra-operative hypothermia and adverse clinical events including surgical site infection would be observed, and costs following these events would be measured. Economic benefit would be analyzed using cost-consequence analysis and cost-utility analysis between two groups. Incremental cost-utility ratio would be used for decision-making. Discussion: Economical evaluation evidence application in insurance entry for pharmaceuticals and medical devices is in its early stage in China. This study may help to provide as a template for trial-based economical evaluation for medical devices. We also hope to promote discussion on proper use of cost-consequences analysis which is less often applied but with high appropriateness in economical evaluation studies for medical devices. Trial registration: Trial registration: This trial was registered on the Chinese Clinical Trial Registry (ChiCTR) on 2017/4/9. ChiCTR is one of the primary registries in the WHO Registry Network. Trial registry number: ChiCTR-IPR-17011099. http://www.chictr.org.c n/edit.aspx?pid=18892&htm=4