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临床试验/NCT05913492
NCT05913492已完成不适用

Difficult Airway Simulation-based Training in Anaesthesiologists: Efficacy and Skills Retention Within Six Months After Training

Bogomolets National Medical University1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2022年7月1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
67
试验地点
1
主要终点
Significant deviations from the DAS protocol

研究概览

简要总结

Difficult airways remain a significant problem in anaesthesia, intensive care and emergency medicine. Simulation-based training gives better outcomes compared to non-simulation and non-intervention education. However, it remains unclear how long the acquired skills are retained and how often simulation training should repeat. The study aimed to investigate the efficacy and skills retention in training for difficult airway management in anaesthesiologists. After ethical committee approval, we conducted a prospective control study at the postgraduate Department of Surgery, Anaesthesiology and Intensive Therapy (Bogomolets National Medical University) from July to December 2022. Anaesthesiologists who applied for the continuous medical education course "Difficult airways management" were involved in the study. The simulation room included a mannequin Laerdal SimMom Advanced Patient Simulator, vital monitor, anaesthesia station LEON and airway devices. Each volunteer went through two simulation scenarios of difficult airway management: 1) "cannot intubate, can ventilate" (CI), 2) "cannot intubate, cannot ventilate" (CICV) with the assistance of the training centre operator. The primary endpoints included: more than three laryngoscopy attempts; supraglottic airway attempt missing; call for help skip; failure to initiate a surgical airway (for the CICV scenario). Secondary endpoints included: time to call for help; mean duration of desaturation; use of bougie; use of video laryngoscope (Airtraq); mean number of intubation attempts; improper usage of equipment of equipment, time to initiation of surgical airway preparation; time to initiation of surgical airway ventilation.

详细描述

After ethical committee approval, we conducted a prospective control study at the postgraduate Department of Surgery, Anaesthesiology and Intensive Therapy (Bogomolets National Medical University) from July to December 2022. Anaesthesiologists who applied for the continuous medical education course "Difficult airways management" were involved in the study. We obtained consent from them to participate anonymously as volunteers. Before the first training, we interviewed all participants about their experience in working in the speciality, difficult airways management, learning at any simulation training and difficult airways training particularly.

The simulation room included a mannequin Laerdal SimMom Advanced Patient Simulator, vital monitor, anaesthesia station LEON and airway devices. Standard settings included modelling of tongue oedema to grade 4 visualizations on laryngoscopy according to the Cormack and Lehane classification, as well as additional pharyngeal obstruction and stiffness of both lungs for the "cannot ventilate" scenario. A standard set of tools and equipment for ensuring airway patency, ventilation and tracheal intubation included facemasks, oropharyngeal and nasal airways, laryngoscopes, laryngeal masks, and tracheal tubes in a range of sizes. The trolley for difficult airways was available for each station and was equipped with additional laryngoscope blades of various sizes, a video laryngoscope, laryngeal masks of various sizes (Igel), introducers for tracheal tubes (stylets and bougies), Airtraq, a cricotomy kit.

Monitoring provided SpO2, EtCO2, ECG and non-invasive blood pressure measurement. When the oxygen delivery was interrupted for 20 seconds or more, the SpO2 gradually decreased by 3% every 5 seconds and reached 90% after 20 seconds. A value of SpO2 < 90% was considered desaturation. Effective ventilation was defined after at least two effective breaths evidenced by an EtCO2 curve on the monitor.

Each volunteer went through two simulation scenarios of difficult airway management: 1) "cannot intubate, can ventilate" (CI), 2) "cannot intubate, cannot ventilate" (CICV) with the assistance of the training centre operator. Participants were expected to follow an algorithm according to the Difficult Airway Society (DAS) recommendations [4].

During the scenario, we recorded significant deviations from the DAS protocol and other indicators that impacted the quality of the algorithm execution. The primary endpoints included significant deviations from the DAS protocol: more than three laryngoscopy attempts; supraglottic airway attempt missing; call for help skip; failure to initiate a surgical airway (for the CICV scenario). Secondary endpoints included: time to call for help; mean duration of desaturation; use of bougie; use of video laryngoscope (Airtraq); mean number of intubation attempts; improper usage of equipment of equipment, time to initiation of surgical airway preparation; time to initiation of surgical airway ventilation Following the first simulation round, volunteers were trained on the same day in difficult airway management according to DAS guidelines, using the same equipment as during the simulation. The participants repeated the simulation scenarios immediately after the training and six months later. The primary and secondary endpoints were compared between three rounds: initial simulation (Group 1), immediately after training (Group 2), and six months after training (Group 3).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult anesthesiologists volunteers

排除标准

  • Refusion to participate, age more than 70 years

结局指标

主要结局

Significant deviations from the DAS protocol

时间窗: 2 hours

more than three laryngoscopy attempts

次要结局

  • Other deviations from DAS protocol(2 hours)

研究者

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

Kateryna Bielka

Associated professor at the Department of OF SURGERY, ANESTHESIOLOGY AND INTENSIVE THERAPY OF POSTGRADUATE EDUCATION

Bogomolets National Medical University

研究点 (1)

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