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临床试验/NCT05197868
NCT05197868已完成不适用

Applied Forces During Neonatal Intubation: a Randomized Crossover Mannequin Study

University Hospital Padova2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年1月20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
30
试验地点
2
主要终点
Forces applied to the epiglottis

研究概览

简要总结

This study will be to compare the forces applied to mannequin airways (at epiglottis and at palate) during direct laryngoscopy and indirect video laryngoscopy with two kinds of blades (straight blade and hyper-angulated blade)

详细描述

This is a randomized controlled crossover trial of intubation with three laryngoscope devices in a neonatal manikin model. Level III NICU and PICU consultants, pediatric residents, anesthesiology consultants, and anesthesiology residents will be eligible to participate in the study. Participants in the ABC arm will be assigned to perform the intubation with a traditional laryngoscope (A), followed by the intubation with a straight blade video laryngoscope (B) and by the intubation with hyper-angulated video laryngoscope (C). Participants in different arms will be assigned to perform the intubations in different sequences (BCA/CAB/ACB/BAC/CBA). The primary outcome measure will be the forces applied to mannequin oro-tracheal tissues during intubation with the three kinds of tools. The secondary outcome measures will be the perceived workload during intubation and intubation time with the traditional laryngoscope and the video laryngoscope.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Level III NICU and PICU consultants, pediatric residents, anesthesiology consultants, and anesthesiology residents will be eligible to participate in the study.

排除标准

  • Refusal to participate.

结局指标

主要结局

Forces applied to the epiglottis

时间窗: 5 minutes

The peak force (maximum force, expressed as Newton) applied on the epiglottis during intubation will be recorded by sensors positioned on the tip of the laryngoscope's blade.

次要结局

  • Forces applied to the palate(5 minutes)
  • Perceived workload during intubation(20 minutes)
  • Time of intubation(5 minutes)

研究者

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

Daniele Trevisanuto

Associate Professor

University Hospital Padova

研究点 (2)

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