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

NCT ID: NCT03253770

Last Updated: 2017-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2017-08-16

Brief Summary

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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.

Detailed Description

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" 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.

Conditions

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Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

SIMMAX2

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

SIMMAX2

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

SIMMAX2

Intervention Type DEVICE

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

Interventions

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SIMMAX2

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

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Claude Bernard University

OTHER

Sponsor Role lead

Responsible Party

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CEJKA Jean-Christophe

MD, PhD, MEng

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centre Lyonnais d'Enseignement par la Simulation en Santé

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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SIMMAX2

Identifier Type: -

Identifier Source: org_study_id

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