Forced air warming vs BARRIER® EasyWarm in perioperative hypothermia

  • Research type

    Research Study

  • Full title

    Evaluation of perioperative core body temperature when using forced air warming or BARRIER® EasyWarm to prevent inadvertent perioperative hypothermia: An open-label, randomized non-inferiority comparison

  • IRAS ID

    142792

  • Contact name

    John Andrzejowski

  • Contact email

    john.andrzejowski@sth.nhs.uk

  • Sponsor organisation

    MÖLNLYCKE

  • Research summary

    Patients undergoing surgery under general anaesthesia will experience varying degrees of hypothermia with a typical core temperature loss of up to three degrees Celsius (°C) in the first three hours. The temperature loss is most pronounced during the first hour of anaesthesia with a lowering of up to 1.6 °C. Identified risk factors for hypothermia development are a low preoperative core temperature, a low body weight, a high age (>60 years) and an ASA grade above 1. Additionally the risk increases with duration of general anaesthesia, the magnitude of surgery and with higher volumes of intravenous fluid infusions. This study will ascertain if active warming with BARRIER® EasyWarm differs compared to active warming with forced air warming in terms of core body temperature perioperatively. Subjects randomized to the investigational group will receive active warming with BARRIER® EasyWarm pre-, intra- and postoperatively. Subjects randomised to the comparator group will receive active warming with forced air warming intraoperatively.

  • REC name

    Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

  • REC reference

    13/YH/0405

  • Date of REC Opinion

    22 Jan 2014

  • REC opinion

    Further Information Favourable Opinion