Clinical Trial: Efficacy of a Convective Prewarming System in Prevention of Perioperative Hypothermia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy of a Convective Prewarming System in Prevention of Perioperative Hypothermia
Brief 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 devi
Detailed Summary:
Sponsor: University of Göttingen
Current Primary Outcome: Core Temperature at end of surgery [ Time Frame: Approximatly 120 minutes (at end of surgery) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of patients with intraoperative hypothermia (Core temperature < 36°C). [ Time Frame: Approximatly 120 minutes (at end of surgery) ]
- Oral temperature before induction of anaesthesia [ Time Frame: at induction of anesthesia ]
- Temperature at arrival in the recovery room [ Time Frame: Approximatly 140 minutes after induction (at arrival in recovery room) ]
Original Secondary Outcome: Same as current
Information By: University of Göttingen
Dates:
Date Received: December 23, 2011
Date Started: October 2011
Date Completion:
Last Updated: March 7, 2012
Last Verified: March 2012
