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临床试验/NCT03741049
NCT03741049已完成不适用

Evaluation of the Novel ScalpelCric Set for Cricothyrotomy Corresponding the Scalpel-Bougie Technique and Comparison With Two Further Techniques of Cricothyrotomy on a Plastic Laryngeal Model (A) and Comparison of the Novel ScalpelCric Set With Surgical Cricothyrotomy in a Porcine Laryngeal Model (B) Influence of Training (A+B) in a Simulation

Johannes Gutenberg University Mainz1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年11月13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
200
试验地点
1
主要终点
Time from initially handling equipment to a successful placement of the endotracheal tube verified by a fiberoptic position check

研究概览

简要总结

During a cannot ventilate cannot intubate situation surgical airway is the last rescue option. Especially in the prehospital setting the airway management seems to be more difficult than in a hospital setting. Nearly all emergency physicians have a limited experience with cricothyrotomy and it is a unclear what method should be taught for this lifesaving procedure, due to lack of data in humans. The aim of this study is to compare the performance of medical personnel (medical students, paramedics, trainee anaesthetists and consultants) in establishing an emergency surgical airway on a plastic laryngeal model and in a porcine laryngeal model using the Scalpel Bougie technique, the Seldinger technique and the common surgical technique.

Furthermore the investigators want to elucidate whether the training of the 3 techniques has an influence in the decision making of the preferred technique in a subsequently simulated cannot ventilate cannot intubate scenario.

详细描述

The investigators plan to recruit medical students (University Mainz), paramedics (employed in ambulance and rescue helicopter), trainee anaesthetists and consultants of the department of anesthesiology from the university hospital Mainz. After written informed consent the participants have to complete an pre-study questionnaire, than the participants get an information sheet about the 3 techniques and the investigators show the participants a short video demonstrating the different techniques. All participants have the opportunity to practice one insertion with each method on a plastic laryngeal model.

After that the participants have to perform each technique on the plastic model and the investigators measure the time from initially handling equipment to the final end-point, which the investigators take as a successful placement of the endotracheal tube verified by a fiberoptic position check.

研究设计

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

入排标准

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

入选标准

  • written informed consent
  • German language in speaking and writing
  • Capability of giving consent

排除标准

  • Participants unwilling or unable to give informed consent

结局指标

主要结局

Time from initially handling equipment to a successful placement of the endotracheal tube verified by a fiberoptic position check

时间窗: up to 3 minutes

次要结局

  • Number of trials(up to 3 minutes)
  • Comfort evaluation by the performer(up to 15 minutes)
  • Dimension of the tracheal trauma(up to 10 minutes)
  • Success rate in the first trial(up to 3 minutes)
  • Influence of training on the time to decision making for cricothyrotomy(up to 5 hours)
  • Influence of training on choosing the technique(up to 5 hours)

研究者

发起方
Johannes Gutenberg University Mainz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nina Pirlich, Dr. med.

Principal Investigator

Johannes Gutenberg University Mainz

研究点 (1)

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