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临床试验/NCT03839017
NCT03839017已完成不适用

Impact on Performance of the Use of a Digital Cognitive Aid in Simulated Crisis and Stress Situations

CEJKA Jean-Christophe2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2019年1月29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
36
试验地点
2
主要终点
Technical Performance: percentage of actions and steps in the MARCHE RYAN protocol performed by each subject with or without the CA MAX

研究概览

简要总结

The previous investigators' studies (MAX, Lelaidier et al, BJA 2017, & SIMMAXMARCHERYAN) clearly showed that the use of a digital cognitive aid in the hand of the leader significantly improves the management of anaesthesia and intensive care emergencies as well as basic combat casualty care.

The present study exclusively deals with the advanced management of simulated combat casualties by military doctors and nurses using the same digital cognitive aid adapted for MARCHE RYAN algorithm.

详细描述

The epidemiology of battlefield mortality highlights the need for safety and speed of care in an environment under very high stress. Indeed, it has been found that about 90% of those killed in action die before reaching the first hospital or care unit. Management algorithms such as ABCDE, SAFE MARCHE RYAN and local protocols are among the many doctrines to be applied by military health professionals when dealing with serious trauma in emergencies in different practice settings. During combat, their actions are carried out under enemy fire, in darkness, in extreme environments, for a significant number of victims and with limited means. As a result, on the battlefield, this multitude of choices and specific conditions of practice can make it difficult to apply the guidelines for the management of war-wounded in critical and stressful situations and can be a source of medical error. Health simulation is one of the main tools for training and preparation in a safe environment for unsafe situations ("never the first time on the patient"). A new decision-making and protocolization tool is available for health professionals: the MAX (Medical Assistant eXpert) cognitive aid, which has already proven its effectiveness in reducing the number of errors in the management of vital distress in anesthesia and in basic combat casualty care.

Materials and Methods:

Population studied: military doctors and nurses from the forces, both male and female, of varying ages and operational experience, planned to be deployed on External Operations (OPEX) or Short-term Mission (MCD), designated by the Val-de-Grâce School as learners for the " Survival Conditioning of the War Wounded " (MCSBG) continuing training course.

Study design (conduct): analytical, prospective, randomized, controlled, unblinded study conducted during the MCSBG training courses as part of the operational preparation of military doctors and nurses of the forces within the Center for Education and Simulation in Operational Medicine (CESimMO) in Toulon. The investigators had four pairs of learners work on one afternoon during each week-long training session. Each pair of learners completed two different scenarios of similar difficulty and complexity. Four blocks of scenarios were defined on which the pairs were able to work. The pairs were initially randomly assigned to two groups: Group 1 where the first scenario was performed with the MAX CA and Group 2 where the CA was used in the second scenario. Each group therefore performed a simulated scenario with and without MAX. The scenarios used either high-fidelity mannequins (SimMan 3G / ALS, Laerdal, Stavanger, Stavanger, Norway) or hybrid standardized patients (standardized subjects equipped with anatomical prostheses that allowed their management including technical procedures).

MAX CA Description: MAX is a digital AC, developed by J.C. CEJKA, and initially intended for the management of anesthesia and resuscitation emergencies. For the MARCHE RYAN protocol, each action was presented sequentially by the CA and had to be validated before the next one was displayed (READ and DO mode). It was possible to go back in order to review the validated actions and at the end of the procedure, the user had the possibility to make a final check of all his actions. The evaluation of the effectiveness of MAX was previously carried out at the Lyon center for teaching through health simulation (CLESS, UCBL1 - Claude Bernard University Lyon 1), but also during the training of Medicalization in hostile environments (MEDICHOS) and the continuing training in 2nd level combat rescue / casualty care (SC).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Single

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

  • Military doctors and Nurses
  • Under initial or continuous training of Combat Casualty Care 3rd level
  • Agreed to use the cognitive aid

排除标准

  • Doesn't agree to use the cognitive aid

结局指标

主要结局

Technical Performance: percentage of actions and steps in the MARCHE RYAN protocol performed by each subject with or without the CA MAX

时间窗: Time 0-30 minutes

As compared to a Reference Task List including between 11 and 16 critical actions to be performed. This grid was used to rate technical performance in each scenario. Each action was recorded: 0 (action not performed), 1 (action performed at the wrong time, with the wrong dosage or inaccurately) or 2 (action performed correctly and at the right time). The individual scores were summed and transformed into a percentage of the maximum achievable score. Statistical analysis and calculation of the number of pairs required: The analysis of the effect of the use of MAX CA on learners' technical performance will be carried out using a 3-factor repeated-measure ANOVA: the use of MAX, the scenario, and whether the scenario is played first or second. A post-hoc analysis by the Bonferroni test will be carried out to compare the groups.

次要结局

  • Non technical skills performance measured using the TEAM scale, MAX+ vs MAX-(Time 0-30 minutes)

研究者

发起方
CEJKA Jean-Christophe
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

CEJKA Jean-Christophe

Teaching Hospital Practitioner

Claude Bernard University

研究点 (2)

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