Purpose Intraoperative and postoperative hypothermia occur commonly; mild hypothermia (34-36°C) is associated with adverse events. The use of perioperative warming devices has become routine, but currently available active warming devices may be limited in certain circumstances. The vitalHEAT TM Temperature Management System provides conductive warming (circulating warm water) around a single extremity together with a vacuum that is applied to the limb. In this randomized trial, we tested the hypothesis that the vitalHEAT TM system is non-inferior to the Bair Hugger Ò during unilateral total knee arthroplasty. Methods Physical status I-III patients who were C18 yrold were eligible to participate. The patients were randomly assigned to the vitalHEAT TM system (n = 30) or to Bair Hugger Ò (n = 25) warming. Intraoperative and first recovery room temperatures were recorded in both groups. Results The baseline characteristics of the groups were similar. In terms of the primary outcome measure, i.e., sublingual temperature measured within 10 min of recovery room arrival, the vitalHEAT TM system did not meet the criterion for non-inferiority. Specifically, the confidence interval for the difference between means included the noninferiority margin (-0.5°C). In terms of the secondary measures, i.e., intraoperative esophageal temperatures, the vitalHEAT TM system also underperformed compared with the Bair Hugger Ò . Conclusions The vitalHEAT TM system may have advantages over convective warming systems because it requires a much smaller body surface area; however, in this study of warming during total knee arthroplasty, it underperformed when compared with the Bair Hugger Ò , especially around and after the time of tourniquet release. Clinical trial registration number: NCT00711867.
RésuméObjectif L'hypothermie perope´ratoire et postope´ratoire est courante; l'hypothermie le´ge`re (34-36°C) est associe´e à des e´ve´nements inde´sirables. Le recours a`des appareils de re´chauffement pe´riope´ratoires est entre´dans la pratique courante, mais les appareils de re´chauffement actif actuellement disponibles sur le marche´pourraient avoir des limites dans certaines circonstances. Le Syste`me de gestion de la tempe´rature vitalHEAT TM procure un re´chauffement par conduction (circulation d'eau chaude) autour d'un seul membre avec un vide et est applique´au membre. Dans cette e´tude randomise´e, nous avons testeT