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临床试验/NCT03491332
NCT03491332Unknown不适用

Effect of Heated Breathing Circuit on Intraoperative Core Temperature and Systemic Inflammation After Brain Surgery: a Prospective Randomized Study

Yonsei University2 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2018年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
117
试验地点
2
主要终点
core temperature

研究概览

简要总结

Mechanical respiration during general anesthesia causes cold and dry gases to reach the lower airway, reduce the function of the airway mucosa, and cause accumulation of secretions. Inhaled dry gas is one of the causes of hypothermia during general anesthesia. To overcome this, the warm-humidifying breathing circuit uses warm, moisture-preserving gas to promote mucus mobility of the airway mucosal ciliate cells and prevents cold gases from evaporating from the mucosal surfaces which results lowering body temperature. We aimed to investigate the effect of newly developed Sohum warm humidifying respiration circuit (SH501) on the prevention of core body temperature reduction during surgery and systemic inflammation reaction.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • scheduled for brain surgery

排除标准

  • patients with severe obstructive lung disease and/or restrictive lung disease patients
  • patients with infectious disease
  • surgery with prone position or lateral position

研究组 & 干预措施

group C

Placebo Comparator

general circuit group

干预措施: conventional circuit (Device)

group H

Active Comparator

warm circuit group

干预措施: conventional humidification circuit (Device)

group SH

Experimental

new warm circuit group

干预措施: new humidifaction heat circuit (Device)

结局指标

主要结局

core temperature

时间窗: every 30 minute after induction of anesthesia until the end of anesthesia

upper airway humidity

时间窗: every 30 minute after induction of anesthesia until the end of anesthesia

upper airway temperature

时间窗: every 30 minute after induction of anesthesia until the end of anesthesia

次要结局

  • respiratory variables(every 30 minute after induction of anesthesia until the end of anesthesia)
  • intrapulmonary shunt(every 30 minute after induction of anesthesia until the end of anesthesia)
  • compliance(every 30 minute after induction of anesthesia until the end of anesthesia)
  • cytokine level(1, 30, 60, 90, 120, 150, 180, 210, 240 minute after induction and 1 second after the operation)
  • dead space(every 30 minute after induction of anesthesia until the end of anesthesia)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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