Perioperative Hypothermia Clinical Trial
Official title:
Efficacy of a Convective Prewarming System in Prevention of Perioperative Hypothermia
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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