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临床试验/NCT04027582
NCT04027582Unknown不适用

Role of Simulators to Assess Simulator-Based Entrusted Professional Activity in Fiber-optic Intubation and Transfer-ability to Clinical Assessment of Anesthesia Trainees in the Competency By Design Residency Program

Mount Sinai Hospital, Canada2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年7月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Cumulative sum learning curve

研究概览

简要总结

Thirty residents in Anesthesia, year one and year two ,and Emergency Medicine Residents, and Family Practice Anesthetists and Emergency residents will undergo teaching in fiber-optic intubation. One half of the group will be randomized to a low fidelity simulator which consists of a wooden block with a series of holes, and the other to a high fidelity simulator, called the ORSIM , which provides a computerised model of the airway. They will practice the procedural skill of fiber-optic intubation on their assigned simulators. Cumulative sum method (CUSUM) learning curves and procedural Entrusted Professional Activities will be obtained for each resident on their assigned simulator. Following this , all residents will undergo a procedural entrusted professional activity with regard to fiber-optic intubation on a low risk , consented patient. The results of the learning curves, Simulator entrusted professional activity and Patient entrusted professional activity will be compared to assess if there is a difference between the low fidelity and high fidelity simulator groups.

详细描述

Fiber-optic intubation(FOI) involves using a thin flexible scope to navigate a breathing tube into a patient's trachea. It is an important skill, as it is required in situations where the breathing tube cannot be inserted using traditional methods. It is a lifesaving skill in terms of securing the 'the difficult airway', in emergency and elective situations. The National Audit Project 4 (NAP4, the largest study on major airway complications in the operating room, emergency department and intensive care unit) have identified the omission of FOI when indicated as a major contributor to airway morbidity and mortality . Recommendations from NAP4 included ensuring anesthesiologists are trained in the use of FOI.

Medical training in Canada and globally is undergoing a major transformation to competency-based medical education (CBME). Within the next decade, all residency programs in Canada will be following a competency-based curriculum, as mandated by the Royal College of Physicians and Surgeons of Canada (Royal College) and the College of Family Physicians of Canada. CBME emphasizes the demonstration of competence in skills and abilities deemed essential for future practice and de-emphasizes time and duration .

While competence is assessed by several metrics in CBME, the entrustable professional activities (EPAs)framework is one approach to assessment. EPAs are specific tasks in the clinical environment that a supervisor will delegate to a resident once sufficient competence has been demonstrated .

Competency-based medical education(CBME) requires residents to demonstrate competency in key skills; simulators have an important role in facilitating this learning in a safe environment without harming patients. Currently, little is known on the role of simulators on acquiring competence of Fiber-optic intubation and assessment of simulator-based Entrusted Professional Activity (EPA) and transfer-ability to patient -based EPA.

The focus of the study is the learning aspect with regards to fiber-optic intubation.

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 (Outcomes Assessor)

盲法说明

The assessors of the video-recorded Simulator EPA and Patient EPA will be blinded as to what group the resident was allocated to . i.e the Low fidelity simulator group or the high fidelity simulator group

入排标准

年龄范围
16 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants:
  • Anesthesia first and second year residents in the Competency-based Medical Education Anesthesia Residency program
  • They must have less than five prior experiences in fiber-optic intubation.
  • Patient inclusion criteria:
  • American Society of Anaesthesiologists classification one and two
  • Normal airway anatomy.

排除标准

  • Patient exclusion criteria:
  • Emergency surgery
  • Risk of aspiration
  • History of Malignant Hyperthermia
  • History of succinylcholine Apnea.
  • American Society of Anaesthesiologists grade greater than two
  • Abnormal airway anatomy
  • Morbid obesity
  • Difficult bag mask ventilation.

研究组 & 干预措施

Low Fidelity Simulator - Wooden block

Active Comparator

This simulator consists of a simple series of wooden panels with holes. The resident learns how to manipulate the fiberoptic bronchoscope through the holes.

干预措施: didactic teaching and simulator practice (Other)

High fidelity Simulator - ORSIM

Active Comparator

The ORSIM® bronchoscopy is a virtual reality simulator (Airway Simulation Limited, Auckland, New Zealand). It consists of hardware and software components that interact to create a high-fidelity virtual reality simulation. A replica fiberoptic scope is advanced by the resident through a desktop sensor, which is connected to a laptop computer. The laptop software program provides a virtual airway in which the user must navigate the probe.

干预措施: didactic teaching and simulator practice (Other)

结局指标

主要结局

Cumulative sum learning curve

时间窗: eight minutes

Primary outcome: Cumulative sum learning curves will be generated as the primary outcome measure as the number of fiber-optics done on each respective simulator to achieve competence, defined as 90% success rate in a series of fiber-optic intubations. Each successful attempt on the respective simulator must be completed within eight minutes (ie apnea time)

次要结局

  • Time(eight minutes)

研究者

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

Eric You-Ten

Associate Professor Anesthesia

Mount Sinai Hospital, Canada

研究点 (2)

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