Efficacy of a Convective Prewarming System in Prevention of Perioperative Hypothermia
Condition: Perioperative Hypothermia
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      Although several measures for prevention of perioperative hypothermia have been introduced
      the last decades, perioperative hypothermia is still a frequent complication and associated
      with a negative outcome.

      For not long lasting surgery without specific risk for hypothermia the standard procedure for
      prevention of perioperative hypothermia is insulation. However, the insulation is often not
      effective enough to prevent intra- and postoperative hypothermia. The implementation of a
      prewarming is difficult because of variable OR schedules and therefore not often applied.

      In the planed prospective, multicenter, randomised-controlled trial will the efficacy of a
      convective prewarming system on prevention of intra- and perioperative hypothermia
      (Thermoflect™, TSCI, Amersfoort, NL) be compared to an intraoperative application of forced
      air warming with or without passive insulation before induction of anesthesia.

      The studied prewarming device is easy to use and will be applied on the nursery ward 30-60
      minutes before transfer of the patient to the OR.

      Perioperative hypothermia is a common complication in general aesthesia. Perioperative
      hypothermia is associated with medical risks as intraoperative impaired coagulation due to
      reversible platelet dysfunction, a prolonged bleeding time and increased intraoperative blood
      loss. In the postoperative course the perioperative hypothermia is especially for patients
      with cardiopulmonary diseases a relevant problem. Not at least sensual cold and shivering is
      uncomfortable for the patient.

      The study is conducted as a multicenter, prospective, randomised controlled trial. All
      patients will receive intraoperatively a forced air warming device (Termoflect™/Mistral Air
      ™). For one intervention group will additionally the insulation with the Thermoflect™ will be
      applied on nursery ward, the second intervention group will receive additionally a convective
      air warmer/ reflective blanket (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL)
      preoperatively on study day on nursery ward.

      The aim of the study is to prove the hypothesis that a preoperative insulation with a
      commercial insulation material (Thermoflect™, TSCI, Amersfoort, NL) leads to a lower
      incidence of perioperative hypothermia in general anesthesia. The second hypothesis is, that
      an active prewarming (Thermoflect™ with Mistral Air™, TSCI, Amersfoort, NL) is associated
      with a more less incidence of periopative hypothermia.
    


Intervention name(s): Thermoflect [TM] passive insulation; Active prewarming (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL)
Intervention type(s): Device; Device
Intervention description(s): passive insulation in the preoperative phase, befor induction of anesthesia; Prewarming Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL before induction of anesthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: perioperative hypothermia; prewarming; forced air warming; insulation