Use of a Hand-held Digital Cognitive Aid in Simulated Cardiac Arrest. (SIMMAX2)
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Lyon, France
- Centre Lyonnais d'Enseignement par la Simulation en Santé
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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. |
Digital cognitive aid or paper cognitive aid during the management of a cardiac arrest in the recovery room or in the delivery room.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
[ Time Frame: Time 0-30 min ]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Non technical skills performance
Time Frame: [ Time Frame: Time 0-30 min ]
|
As measured by the Ottawa score, rated on remote video review
|
[ Time Frame: Time 0-30 min ]
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SIMMAX2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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