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临床试验/NCT01502163
NCT01502163已完成不适用

Efficacy of a Convective Prewarming System in Prevention of Perioperative Hypothermia

University of Göttingen4 个研究点 分布在 3 个国家目标入组 90 人开始时间: 2011年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
4
主要终点
Core Temperature at end of surgery

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 18 to 75 years
  • BMI from 20 to 30 kg/m2
  • Risk class ASA I to III
  • Scheduled time for surgery 30 to 120 minutes
  • Scheduled anaesthesia with remifentanil, propofol, rocuronium and sevofluran
  • Ability of informed consent

排除标准

  • Adipositas permagna
  • Risk class ASA IV to V
  • Hypo- and Hyperthyroidism
  • Febrile infection
  • Pregnancy
  • Scheduled time for surgery < 30 or > 120 minutes
  • Known incompatibility for midazolam, remifentanil, propofol oder rocuronium

结局指标

主要结局

Core Temperature at end of surgery

时间窗: Approximatly 120 minutes (at end of surgery)

次要结局

  • Number of patients with intraoperative hypothermia (Core temperature < 36°C).(Approximatly 120 minutes (at end of surgery))
  • Oral temperature before induction of anaesthesia(at induction of anesthesia)
  • Temperature at arrival in the recovery room(Approximatly 140 minutes after induction (at arrival in recovery room))

研究者

发起方
University of Göttingen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. T. Perl

Principal investigator

University of Göttingen

研究点 (4)

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