Intraoperative Warming Comparison of Devices
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      Hypothermia is a common and serious complication during anesthesia and surgery.
      Anesthetic-induced hypothermia results from the inhibition of thermoregulatory control and
      exposure to cold operating room environment.

      Various warming methods, such as warm blankets, forced-air warmers and circulating water
      mattresses, are currently used to prevent and treat mild perioperative hypothermia. All are
      cutaneous approaches that rely on heating the peripheral tissues in order to increase the
      thermal core temperature. Application of cutaneous warming system blankets/pads are limited
      by location/extent of operative site; for example, in certain procedures such as
      laparatomies, reconstructive plastic surgery or orthopedic surgery, only a limited amount of
      skin surface is available for warming application. The Dynatherm vitalHEAT technology takes
      advantage of the body's natural thermoregulatory system to channel thermal energy to the
      body's core non-invasively at a rapid rate. The vital heat (vH2) system is designed to treat
      hypothermia during the peri-operative period through a combination of localized heat and
      vacuum application to one hand & forearm; this application 1) opens the arteriovenous
      anastamoses located in the palm of the hand and 2) conductively warms the extremity thus
      effectively warming the blood flow to the body's core. The vital heat vH2 system is a
      portable and compact warming device which provides a non-invasive approach to warming
      patients during surgery.

      The primary objective of this study is to determine if the Dynatherm Medical vitalHEAT (vH2)
      Temperature Management System is as effective as the forced-air warming Bair Hugger™ (Arizant
      Healthcare, Eden Prairie, MN) for maintenance of intraoperative body temperature in patients
      undergoing abdominal surgery under general anesthesia. The critical endpoints to be evaluated
      in making this determination are 1) % of subjects with an average intraoperative esophageal
      temperature of ≥ 36º C and 2) % of subjects with an initial post anesthesia care unit
      sublingual temperature of ≥ 36º C. Secondary objectives include 1) comparison of the core
      body temperatures @ 60 minutes post anesthesia induction, 2) comparison of temperature trends
      during surgery and 3) comparison of the subjects' post anesthesia care unit temperature
      trends and hypothermic symptoms such as shivering.
    


Intervention name(s): Dynatherm Medical vitalHEAT Temperature Management System vH2; Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN)
Intervention type(s): Device; Device
Intervention description(s): The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical.; The Bair Hugger system is the current standard of care at Tampa General Hospital. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket.
Other intervention name(s): Part number VH-200; Model 522
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: intraoperative warming; anesthesia; hypothermia; body temperature