RESUMEN
BACKGROUND: A recent heat-balance study in volunteers suggested that greater efficacy of circulating-water garments (CWGs) results largely from increased heat transfer across the posterior skin surface since heat transfer across the anterior skin surface was similar with circulating-water and forced-air. We thus tested the hypothesis that the combination of a circulating-water mattress (CWM) and forced-air warming prevents core temperature reduction during major abdominal surgery no worse than a CWG does. METHODS: Fifty adult patients aged between 18 and 85 yr old, undergoing major abdominal surgery, were randomly assigned to intraoperative warming with a combination of forced-air and a CWM or with a CWG (Allon ThermoWrap). Core temperature was measured in the distal oesophagus. Non-inferiority of the CWM to the CWG on change from baseline to median intraoperative temperature was assessed using a one-tailed Student's t-test with an equivalency buffer of -0.5°C. RESULTS: Data analysis was restricted to 16 CWG and 20 CWM patients who completed the protocol. Core temperature increased in both groups during the initial hours of surgery. We had sufficient evidence (P=0.001), to conclude that the combination of a CWM and forced-air warming was non-inferior to a CWG in preventing temperature reduction, with mean (95% CI) difference in the temperature change between the CWM and the CWG groups (CWM-CWG) of 0.46°C (-0.09°C, 1.00°C). CONCLUSIONS: The combination of a CWM and forced-air warming is significantly non-inferior in maintaining intraoperative core temperature than a CWG. TRIAL REGISTRY: This trial has been registered at clinical trials.gov, identifier: NCT 00651898.