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临床试验/NCT03876808
NCT03876808终止不适用

A Prospective Randomized Clinical Trial Evaluating the Effect of Convective Pre-warming on Intra-operative Thermoregulatory Capabilities in Patients Enrolled in the TIGER Anesthesia Perioperative Protocol

University of Missouri-Columbia1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年10月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
10
试验地点
1
主要终点
Core Body Temperature

研究概览

简要总结

This prospective randomized clinical trial will assess the effect of pre-operative convective warming on intra-operative thermoregulation in patients undergoing gastrointestinal or genitourinary surgical procedures with the Tiger anesthesia perioperative protocol.

详细描述

By the year 2030 the geriatric presence in the United States, defined as any adult >65 years of age, is estimated to reach around 20% of the entire population. Thus, understanding medical concepts as they relate to the elderly is becoming increasingly important. One such concept is that of hypothermia - a core body temperature < 36°C - for which age >65 has been found to be an independent risk factor. This complication is especially prevalent intra-operatively due to use of general anesthetics, cool ambient operating room (OR) temperatures, and impaired thermal regulation in the elderly.

The human body employs numerous mechanisms to maintain thermal homeostasis including: behavioral means of thermoregulation, sweating, pre-capillary vasodilation, non-shivering and shivering means of heat production, and arteriovenous shunt vasoconstriction. The first, and arguably most important, regulatory response to occur is that of vasoconstriction, which normally results in redistribution of blood from the relatively cool periphery to the warmer core compartment in order to confine metabolic heat to the central tissues. Patients undergoing general anesthesia experience reduced vasoconstriction due to decreased cold response thresholds while patients undergoing epidural anesthesia experience sympathetic blocks resulting in blunted vasoconstrictive responses. All patients experience the afore mentioned side effects of anesthetics, however it has been proven that the elderly are more susceptible to hypothermia due to lower vasoconstriction thresholds - determined by a temperature gradient of 4°C between the periphery and core.

First explored by Kurz et al. in 1993, it was found that use of nitrous oxide and isoflurane anesthesia lead to an approximately 1.2°C lower vasoconstriction threshold of 33.9±0.6 in the elderly versus 35.1±0.3 in the young (p < .01). This subject was again looked at in a 1997 study wherein the vasoconstriction threshold during nitrous oxide and sevoflurane was observed to be decreased by approximately 0.8°C in the elderly at 35.0±0.8 versus 35.8±0.3 in the young (p < .01). This is relevant because intraoperative hypothermia has long been known to lead to adverse outcomes such as increased incidence of myocardial ischemia, arrhythmias, coagulopathic states, and wound infections. In a 2014 retrospective cohort study by Billeter et al. patient's experiencing core temperatures <35°C had a four times increase in mortality with complication rates increasing two fold and incidence of stroke increasing six fold. To counter this thermoregulatory failure in patients, numerous methods of warming have been practiced over time to augment the normal body response.

One method used to decrease intraoperative hypothermia is warming patients before surgery via skin surface warmers. Numerous studies have found that even brief periods of pre-warming can improve intraoperative temperatures significantly for as long as 75-90 minutes after induction. In procedures lasting less than 90 minutes, Horn et al. found that as little as 10 minutes of pre-warming decreased incidence of intraoperative hypothermia from 69% to just 13% while Torossian et al. decreased the incidence from 60% to 38% in his study using a self-warming blanket for 30 minutes pre-operatively. Studies have also shown that longer pre-warming, of 45-60 minutes, can prevent hypothermia for up to 2 hours after induction.

While significant research has been performed on the effects of warming patients before they undergo surgical procedures, scant evidence demonstrates the effect of pre-warming in the elderly. In one article specifically looking at pre-warming in the elderly (mean age ~72-73) it was found that, after pre-warming for 20 minutes, there was no significant change in incidence of hypothermia but there was a significant difference in severity of hypothermia when it did occur. This study focused only on men undergoing transurethral resection of the prostate however, and suffers from lack of generalizability. With the proportion of the geriatric population continuing to expand, and the potential adverse effects resulting from their increased susceptibility to intraoperative hypothermia, it is of the utmost importance to look into methods to counter this dilemma and expand the database on the topic.

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

盲法说明

At time of consent the randomization is masked for the participant, care provider, and investigator. Once randomization has occurred there is no masking as you clearly know what group has been assigned.

入排标准

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

入选标准

  • •Other inclusion criteria as delineated in the TIGER anesthesia perioperative protocol

排除标准

  • •Inability to obtain written informed consent
  • •Inability to obtain core body temperature recordings
  • •Family history of malignant hyperthermia
  • •Preoperative temperature > 38° C
  • •Other exclusion criteria as delineated in the TIGER anesthesia perioperative protocol

研究组 & 干预措施

Convective pre-warming

Experimental

Undergo convective warming during the preoperative preparations, completed for a minimum of 60 minutes prior to entering the operating room

干预措施: Bair Hugger™ Temperature Management Unit Model 750 (Device)

Convective pre-warming

Experimental

Undergo convective warming during the preoperative preparations, completed for a minimum of 60 minutes prior to entering the operating room

干预措施: 3M™ Bair Paws™ Flex Gown (Device)

Standard of care

No Intervention

Undergo standard of care, which includes providing each patient with blankets and sheets, as well as more blankets on patient request.

结局指标

主要结局

Core Body Temperature

时间窗: Day 1

Change in core temperature between induction of anesthesia and end of skin preparation

次要结局

  • Temperature Differences Between Different Age Groups(Day 1)
  • Skin Temperature(Day 1)
  • Intraoperative Temperatures(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Boris Mraovic

Associate Professor

University of Missouri-Columbia

研究点 (1)

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