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临床试验/NCT04050241
NCT04050241已完成不适用

Objective and Subjective Mental Workload During Direct and Indirect Laryngoscopy in Anesthetists: an In-vivo, Cross-over Randomized Study

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年6月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
试验地点
2
主要终点
Perceived workload

研究概览

简要总结

The study evaluates differences in perceived and objective workload in anesthetists during intubation procedure with a direct (Mcintosh) or indirect (Glidescope) laryngoscope. Expert anesthetists will perform 3 intubations per device, while completing a secondary task, during which reaction times to an auditory stimulus will be recorded, and will complete a questionnaire (the NASA-Task Load Index) to evaluate their perceived workload at the end of each procedure.

详细描述

Intubation and laryngoscopy are the most demanding procedure in anesthesiological routine clinical practice, associated with high workload. The measurement and management of workload is considered important in anesthesiology to prevent work-related stress and errors in performance. New devices, thanks to advances in technology, seem promising in reducing operators' workload and improving safety and success of intubation processes.

Therefore, in this study, based on previous results, the hypothesis that the Glidescope videolaryngoscope reduces operators' perceived and and objective workload, as compared to the standard Mcintosh laryngoscope, will be tested.

Expert anesthetists will perform 3 intubations per device in a randomized order, while completing a secondary task, during which reaction times (verbal responses) to an auditory stimulus (a clacson) will be recorded, and operators will complete a questionnaire (the NASA-Task Load Index) to evaluate their perceived workload at the end of each procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Anesthetists with expertise in videolaryngoscopy and direct laryngoscopy that give consent to participate

排除标准

  • Anesthetists that refuse to participate
  • Anesthetists without expertise in videolaryngoscopy and direct laryngoscopy that give consent to participate
  • Anesthetists that have left hearing loss

研究组 & 干预措施

Videolaryngoscope

Experimental

Anesthetists performing intubation with the Glidescope videolaryngoscope.

干预措施: Glidescope intubation (Device)

Direct laryngoscope

Experimental

Anesthetists performing intubation with the Mcintosh laryngoscope.

干预措施: Mcintosh intubation (Device)

结局指标

主要结局

Perceived workload

时间窗: Immediately after the procedure/intervention

Results from the self-reported NASA Task Load Index will be considered as measure of perceived subjective workload

次要结局

  • Quantitative workload(During the laryngoscopy/intubation procedure)

研究者

发起方
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eleonora Orena

Senior Researcher

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

研究点 (2)

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