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临床试验/NCT02518815
NCT02518815已完成不适用

Preoperative Active Warming Prevents Postoperative Hypothermia in Patients Undergoing Laparoscopic Gynecologic Surgery. A Randomized Control Trial

Michael Garron Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2013年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Oral temperature immediately postoperatively

研究概览

简要总结

This study examined whether 20 minutes of prewarming prior to gynecological laparoscopic surgery prevented inadvertent post-operative hypothermia. Treatment group received prewarming using a forced air body warming, control group received no active warming system. Both groups were then warmed with forced air warmer intraoperatively.

详细描述

Inadvertent perioperative hypothermia is a well known perioperative complication. The behavioural response to hypothermia is the most powerful protective tool, more effective than any autonomic response, and is obviously removed in the operative setting. Anesthesia alters thermoregulation by profoundly changing the thresholds for vasoconstriction and shivering, making patients vulnerable to the adverse outcomes related to mild hypothermia. Inadvertent postoperative hypothermia can occur in up to 70% of surgical patients. It is defined as a core temperature below 36°C (96.8°F). The aim of this study was to determine if prewarming with an active warming system for 20 minutes preoperatively could prevent postoperative inadvertent hypothermia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •ASA I-III
  • •undergoing elective laparoscopic gynecological surgical procedures
  • •expected duration >60 minutes
  • •BMI 18-45

排除标准

  • •Current fever (temperature>38.1°C)
  • •active endocrine disorders were exclusion criteria

研究组 & 干预措施

Prewarming group

Experimental

Prewarmed for 20 minutes prior to OR using 3M Bair Paws System, a forced air warming blanket. This warming blanket was then used intraoperatively throughout the case.

干预措施: 3M Bair Paws Warming System (Device)

Control group

No Intervention

Patients received standard care, which is no active prewarming prior to OR. A full body, forced air warming blanket (same as treatment group) was used intraoperatively throughout the case.

结局指标

主要结局

Oral temperature immediately postoperatively

时间窗: Immediately post-operatively

Immediate postoperative oral temperature on admission to the post-anesthetic care unit.

次要结局

  • Oral temperature at discharge from post-anesthetic care unit(Discharge from post-anesthetic care unit (average 99 minutes))
  • 11-point Pain score(30 min after admission to post-anesthetic care unit)
  • Oral temperature 30 minutes postoperatively(30 min after admission to post-anesthetic care unit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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