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Use of a Hand-held Digital Cognitive Aid in Simulated Cardiac Arrest. (SIMMAX2)

2017年8月17日 更新者:CEJKA Jean-Christophe、Claude Bernard University

Cardiac arrest is one of the most stressful situations to be managed. Our first study (MAX, accepted for publication BJA) clearly showed that it could not be compared to other urgent and stressful situations (malignant hyperthermia, anaphylactic shock, acute toxicity of local anesthetics, severe and symptomatic hyperkaliemia) whose management was significantly improved with the help of a digital cognitive aid.

The present study exclusively deals with the management of cardiac arrest (recovery ward, or in the delivery room.) with the second generation of our digital cognitive aid, and explores new insights on how to better manage cardiac arrest with a digital cognitive aid in the hand of the leader.

研究概览

地位

完全的

条件

干预/治疗

详细说明

" Errare humanum est ", to err is human. This Latin saying attributed to Seneca shows that since the dawn of time, human beings are aware that managing complex situations will always be an inexhaustible source of mistakes. This is particularly true in anesthesia and intensive care in which situations are often complex and stressful, thus leading to mistakes or inadequate management. Improvement might arise from the use of cognitive aids.

In a first study (MAX, accepted for publication BJA) the investigators designed a smartphone application including 5 scenarios of anesthesia and intensive care crises (malignant hyperthermia, anaphylactic shock, acute toxicity of local anesthetics, severe and symptomatic hyperkaliemia, ventricular fibrillation), designed to be used in the hand of the leader managing the crises. Technical and non technical skills were improved in 4 out of 5 scenarios. Cardiac arrest (ventricular fibrillation) clearly happened to be a different situation compared to other crises, and no improvement could be measured with our cognitive aid.

The present study exclusively deals with the management of cardiac arrest (man in recovery ward, pregnant woman in the delivery room) with the second generation of our digital cognitive aid, and explores new insights on how to better manage cardiac arrest with a digital cognitive aid in the hand of the leader.

研究类型

介入性

注册 (实际的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Lyon、法国
        • Centre Lyonnais d'Enseignement par la Simulation en Santé

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:•

  • Resident Physicians training in Anesthesia/Intensive care (same specialization in France), year 1 to 5 (out of 5)
  • to be familiar with our simulation centre (at least passed once as a resident)

Exclusion Criteria:

  • no experience in simulation training

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Digital Cognitive Aid
The digital cognitive aid is designed as a smartphone app. Intervention : cognitive aid in the hand of the leader during crises management.
Digital cognitive aid or paper cognitive aid during the management of a cardiac arrest in the recovery room or in the delivery room.
实验性的:No digital aid
No cognitive aid in the hand of the leader during crises management. Intervention : no cognitive aid in the hand of the leader during crises management.
Digital cognitive aid or paper cognitive aid during the management of a cardiac arrest in the recovery room or in the delivery room.
实验性的:Paper Cognitive Aid

The paper cognitive aid is the document officially recommended to be used in case of crises by the French Society of Anaesthesia and Intensive Care.

Intervention : paper cognitive aid in the hand of the leader during crises management.

Digital cognitive aid or paper cognitive aid during the management of a cardiac arrest in the recovery room or in the delivery room.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Technical Performance as compared to a Reference Task List
大体时间:[ Time Frame: Time 0-30 min ]
Number of tasks successfully performed, rated on remote video review
[ Time Frame: Time 0-30 min ]

次要结果测量

结果测量
措施说明
大体时间
Non technical skills performance
大体时间:[ Time Frame: Time 0-30 min ]
As measured by the Ottawa score, rated on remote video review
[ Time Frame: Time 0-30 min ]

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年5月1日

初级完成 (实际的)

2017年8月1日

研究完成 (实际的)

2017年8月16日

研究注册日期

首次提交

2017年8月16日

首先提交符合 QC 标准的

2017年8月16日

首次发布 (实际的)

2017年8月18日

研究记录更新

最后更新发布 (实际的)

2017年8月22日

上次提交的符合 QC 标准的更新

2017年8月17日

最后验证

2017年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • SIMMAX2

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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