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临床试验/NCT03976726
NCT03976726已完成不适用

Influence of Temperature on Volume, Weight and Density Changes of I-gel® Masks

Johann Wolfgang Goethe University Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年4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
15
试验地点
1
主要终点
Volume

研究概览

简要总结

The i-gel® mask is a second generation, single use supraglottic airway device which does not have an inflatable cuff. The cuff consists of a thermoplastic elastomer and its mechanism of sealing still remains unclear. Various theories such as temperature-dependent changes in hardness and volume expansion as well as fluid absorption have been discussed.

详细描述

The i-gel® mask (Intersurgical, Workingham, UK), is a second generation, single use supraglottic airway device. In contrast to other devices its' cuff consists of a thermoplastic elastomer (styrene-ethylene-butadine-styrene) instead of an inflatable cuff.

Previous studies have shown, that over time the sealing improved compared to the moment of insertion. The sealing process may be based on various mechanisms. It is assumed, that the warming from room to body temperature leads to an improved adaptation to the patient-specific anatomy due to a softening of the elastomer. By definition, an elastomer is softened by the effect of temperature and become harder when reaching the glass transition temperature.

In this context, Dingley et al. described a change in the degree of hardness as a function of temperature. Prewarmed i-gel® masks (42°C, 30min.) seem to have smaller leak volumes compared to masks stored at room temperature postinsertion in paralyzed patients, but was not reproducible in non-paralyzed patients. Looking at the sealing pressure Chauhan et al. reported that i-gel® masks required a lower pressure compared to masks with an inflatable cuff.

At this point it is not yet clear, whether the thermoplastic cuff material only expands due to an increase in temperature. Liquid absorption and a consecutive expansion is also theoretically conceivable.

Therefore, the aim of the present study is to examine the i-gel® mask within the scope of a benchtop study for temperature-dependent volume expansion and liquid absorption.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Elective surgery

排除标准

  • Contraindications for the use of i-gel masks.
  • Emergency operation
  • non fasted patient

结局指标

主要结局

Volume

时间窗: Two consecutive measurements within 15 minutes once the mask temperature has cooled from body temperature to room temperature.

Changes of masks volume.

Weight

时间窗: Two consecutive measurements within 15 minutes once the mask temperature has cooled from body temperature to room temperature.

Changes of masks weight.

Density

时间窗: Two consecutive measurements within 15 minutes once the mask temperature has cooled from body temperature to room temperature.

Changes of masks density.

次要结局

未报告次要终点

研究者

发起方
Johann Wolfgang Goethe University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. med. Florian Raimann

Principal Investigator

Johann Wolfgang Goethe University Hospital

研究点 (1)

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