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

Cardiac Arrest Clinical Trial

— SIMMAX2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03253770
• Other study ID #: SIMMAX2
• Status: Completed
• Phase: N/A
• First received: August 16, 2017
• Last updated: August 17, 2017
• Start date: May 1, 2017
• Est. completion date: August 16, 2017

Study information

• Verified date: August 2017
• Source: Claude Bernard University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 16, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

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.

Locations

Country	Name	City	State
France	Centre Lyonnais d'Enseignement par la Simulation en Santé	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Claude Bernard University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical Performance as compared to a Reference Task List	Number of tasks successfully performed, rated on remote video review	[ Time Frame: Time 0-30 min ]
Secondary	Non technical skills performance	As measured by the Ottawa score, rated on remote video review	[ Time Frame: Time 0-30 min ]