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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03253770
Recruitment Status : Completed
First Posted : August 18, 2017
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
CEJKA Jean-Christophe, Claude Bernard University

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cardiac Arrest Device: SIMMAX2 Not Applicable

Detailed Description:

" 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Use of a Hand-held Digital Cognitive Aid in Simulated Cardiac Arrest.
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : August 16, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: SIMMAX2
Digital cognitive aid or paper cognitive aid during the management of a cardiac arrest in the recovery room or in the delivery room.
Experimental: 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.
 Device: SIMMAX2
Digital cognitive aid or paper cognitive aid during the management of a cardiac arrest in the recovery room or in the delivery room.
Experimental: 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.

 Device: SIMMAX2
Digital cognitive aid or paper cognitive aid during the management of a cardiac arrest in the recovery room or in the delivery room.


Outcome Measures
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Primary Outcome Measures :
  1. Technical Performance as compared to a Reference Task List [ Time Frame: [ Time Frame: Time 0-30 min ] ]
    Number of tasks successfully performed, rated on remote video review


Secondary Outcome Measures :
  1. Non technical skills performance [ Time Frame: [ Time Frame: Time 0-30 min ] ]
    As measured by the Ottawa score, rated on remote video review


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253770


Locations
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France
Centre Lyonnais d'Enseignement par la Simulation en Santé
Lyon, France
Sponsors and Collaborators
Claude Bernard University
More Information
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Responsible Party: CEJKA Jean-Christophe, MD, PhD, MEng, Claude Bernard University
ClinicalTrials.gov Identifier: NCT03253770    
Other Study ID Numbers: SIMMAX2
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CEJKA Jean-Christophe, Claude Bernard University:
Cognitive Aid
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases