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临床试验/NCT04601636
NCT04601636已完成不适用

Comparison of Continuous Active Prewarming Using Flex Warming Gown (3M) Versus Standard Care to Prevent Perioperative Hyporthermia in Short Outpatient Surgery Under General Anesthesia

Ciusss de L'Est de l'Île de Montréal2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年10月26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
60
试验地点
2
主要终点
Temperature at the end of surgery (°Celsius)

研究概览

简要总结

The purpose of this prospective randomized controlled study is to compare the efficiency in preventing perioperative hypothermia of a continuous active prewarming combined with active intraoperative warming versus passive prewarming plus intraoperative warming for short outpatient surgery.

详细描述

The prevalence of accidental perioperative hypothermia is high, ranging from 20 to 90% in the literature, and its prevention still remains a major issue despite the many existing prevention techniques. Perioperative hypothermia is defined as a core body temperature below 36.0 ° Celsius.

The deleterious effects of perioperative hypothermia are well known : increased risk of wound infection, adverse cardiac events and blood loss. Moreover, the pharmacology of anesthetic agents can be altered by hypothermia, which in turn could lengthen the emergence of anesthesia. Patient comfort and satisfaction are also related to hypothermia and the feeling of cold generated.

Thus, hypothermia may be associated with prolonged length of stay in the recovery room and in the hospital for outpatient surgeries. Therefore, hypothermia can indirectly increase the costs of an intervention.

Several techniques have been described for the prevention of perioperative hypothermia. Passive warming is a method used to prevent heat loss such as warm cotton blankets, drapes or plastics whereas active warming consist in adding heat to the body surface using a warming system such as forced-air warming to increase mean body temperature. So, the use of a prewarming, an active warming before induction of anesthesia, could reduce the potential for redistribution, the main mechanism of hypothermia under general anesthesia.

Based on a literature review, the combined use of active prewarming with intraoperative active warming appears to be the most effective technique in preventing hypothermia upon arrival in the recovery room for inpatient surgeries lasting longer than 30 minutes. In the literature, the majority of publications on prewarming focus on surgeries lasting at least one hour, despite strong recommendations to use active warming for surgeries of 30 minutes or more. There is not so much data regarding the efficiency of continuous prewarming for short outpatient surgeries, from the preoperative unit to induction of anesthesia.

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
None

入排标准

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

入选标准

  • ASA Physical Status I to III
  • Elective Outpatient Surgery under General Anesthesia
  • Surgery Length from 30 to 120 minutes (from induction of anesthesia to extubation)

排除标准

  • Patient refusal or inability to consent
  • Neuraxial (spinal or epidural) anesthesia
  • BMI over 40 (Flex gown limitation)
  • Pregnancy
  • Active infection
  • Systemic disease which impairs thermoregulation (hypothyroidism or hyperthyroidism, adrenal insufficiency, major burns, para / quadriplegia)
  • Medications affecting core body temperature (like levothyroxine)
  • Facial surgery
  • Use of a fluid warmer

结局指标

主要结局

Temperature at the end of surgery (°Celsius)

时间窗: Measure taken at the end of surgery, before the patient leaves the operating room for the recovery room (below 120 minutes)

Patient Temperature at the end of surgery

次要结局

  • Shivering incidence (number of episodes)(Length of Stay in the Recovery Room (maximum 2h))
  • Recovery Room Length of Stay (minutes)(Length of Stay in the Recovery Room (maximum 2h))
  • Incidence of Hypothermia (presence or absence)(Intraoperative (time frame when patient is in the operative room - below 120 minutes))
  • Delta Temperature Loss (°Celsius)(Intraoperative (time frame when patient is in the operative room - below 120 minutes))
  • Grade of Shivering (likert scale 0 to 4)(Length of Stay in the Recovery Room (maximum 2h))
  • Patient Comfort Level (likert scale 0 to 10)(Right before entry in the operating room)

研究者

发起方
Ciusss de L'Est de l'Île de Montréal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Philippe Richebe

Professor, MD, PhD, DESAR, Chair of Research

Ciusss de L'Est de l'Île de Montréal

研究点 (2)

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