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临床试验/NCT03619057
NCT03619057已完成不适用

Voice Tessitura and Size of the Required Laryngeal Mask

Centre Hospitalier Intercommunal Creteil1 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
161
试验地点
1
主要终点
Concordance between the weight and the tessitura threshold

研究概览

简要总结

The choice of the size of the laryngeal mask (i-gel) is based on the weight. Even following the weight recommendations, it is quite common to choose a mask that is too big or too small, which leads to ventilation leaks (too small), or insertion failures (too big) and leads to a change of mask for bigger or smaller.

The i-gel are laryngeal masks (2nd generation) which consist of gel and have been designed by molding on larynx corpses. The masks are not inflatable (so not adaptable).

I-gel masks are used in adult and pediatric patients for weights ranging from 2 Kg to over 90 Kg to provide ventilation during general anesthesia.

Patients with a deep voice probably need a larger laryngeal mask than their weight alone suggests.

The investigators propose to measure the lowest sound emitted by the patient because it would seem logical that the larger the larynx is, the more the voice is serious.

This hypothesis will be verified a posteriori by the size of the laryngeal mask used and adapted by comparing it to the range of the voice.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age ≥ 10 years
  • Planned surgical procedure with the use of a laryngeal mask

排除标准

  • Refusal to participate in the study.

结局指标

主要结局

Concordance between the weight and the tessitura threshold

时间窗: 1 day

Concordance between the size of the mask proposed as a function of the weight and that determined after determination of the tessitura threshold for each mask size by ROC curves.

次要结局

  • Determining the tessitura threshold corresponding to each mask size(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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