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临床试验/NCT06525662
NCT06525662招募中不适用

Randomised Controlled Trial of Stylet Shape in Simulated Endotracheal Intubation by Medical Students

National University Hospital, Singapore1 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2024年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
268
试验地点
1
主要终点
Time to successful intubation

研究概览

简要总结

Endotracheal intubation is a life saving procedure where a tube is placed into a person's windpipe to help them to breathe. This is a study of which shape of tube would lead to improved success in this procedure.

详细描述

Endotracheal intubation (ETI) is a lifesaving procedure. It involves placing a tube in the patient's airway to maintain ventilation and oxygenation.

Simulation has been shown to be effective for medical procedural skills training. Medical simulation literature now focuses on instructional design (ID) features that improve learning.

There are multiple aspects of ETI technique and ID that can be modified to improve successful ETI. Patient positioning, mastery learning, and dyad rather than solo practice are examples for which evidence exists to guide instructors. Despite this, ETI complication rates are substantial.

Thus, areas for continued improvement in ETI ID should be explored. One area is the optimal endotracheal tube (ETT) shape, achieved using a stylet, for novices learning ETI, for which there is limited evidence.

The straight to cuff (STC) shape has been postulated to optimise views of the airway compared to an arcuate shape. These shapes have only been directly compared as subgroups among multiple other comparisons in ETI technique in difficult intubations in one study. This does not generalise well to educating novices such as medical students, where intubations at normal difficulty are within the learner's zone of proximal development, and findings from subgroup comparisons are hypothesis generating rather than definitive evidence

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Care Provider)

盲法说明

The instructors teaching students how to use the different stylet shapes will be masked regarding the study hypothesis and participant group allocation. It will be emphasised to instructors that each participant has an equal amount of time to learn to use both shapes.

入排标准

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

入选标准

  • Final year medical students in the Yong Loo Lin School of Medicine, National University of Singapore, undergoing their simulation posting. Endotracheal intubation is a procedure that is taught during this posting.

排除标准

  • Injuries precluding performance of endotracheal intubation. Non exhaustive examples include arm injuries.

结局指标

主要结局

Time to successful intubation

时间窗: Outcome assessment will occur within 2 weeks of endotracheal intubation being taught to participants, and immediately upon randomisation to a specified shape to attempt endotracheal intubation under video recording

Defined as the time between insertion of the laryngoscope to successful placement of the tube in the trachea

次要结局

  • Proportion of participants who successfully intubate on first pass of laryngoscope(Outcome assessment will occur within 2 weeks of endotracheal intubation being taught to participants, and immediately upon randomisation to a specified shape to attempt endotracheal intubation under video recording)
  • Proportion of participants who perform an oesophageal intubation(Outcome assessment will occur within 2 weeks of endotracheal intubation being taught to participants, and immediately after their intubation attempt under video recording)
  • Proportion of participants who successfully intubate on first pass of endotracheal tube(Outcome assessment will occur within 2 weeks of endotracheal intubation being taught to participants, and immediately upon randomisation to a specified shape to attempt endotracheal intubation under video recording)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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