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

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SIMMAX2
Sponsored by
Claude Bernard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Cognitive Aid

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre Lyonnais d'Enseignement par la Simulation en Santé

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Digital Cognitive Aid

No digital aid

Paper Cognitive Aid

Arm Description

The digital cognitive aid is designed as a smartphone app. Intervention : cognitive aid in the hand of the leader during crises management.

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.

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.

Outcomes

Primary Outcome Measures

Technical Performance as compared to a Reference Task List
Number of tasks successfully performed, rated on remote video review

Secondary Outcome Measures

Non technical skills performance
As measured by the Ottawa score, rated on remote video review

Full Information

First Posted
August 16, 2017
Last Updated
August 17, 2017
Sponsor
Claude Bernard University
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1. Study Identification

Unique Protocol Identification Number
NCT03253770
Brief Title
Use of a Hand-held Digital Cognitive Aid in Simulated Cardiac Arrest.
Acronym
SIMMAX2
Official Title
Use of a Hand-held Digital Cognitive Aid in Simulated Cardiac Arrest.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
August 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Claude Bernard University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Cognitive Aid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital Cognitive Aid
Arm Type
Experimental
Arm Description
The digital cognitive aid is designed as a smartphone app. Intervention : cognitive aid in the hand of the leader during crises management.
Arm Title
No digital aid
Arm Type
Experimental
Arm Description
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.
Arm Title
Paper Cognitive Aid
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SIMMAX2
Intervention Description
Digital cognitive aid or paper cognitive aid during the management of a cardiac arrest in the recovery room or in the delivery room.
Primary Outcome Measure Information:
Title
Technical Performance as compared to a Reference Task List
Description
Number of tasks successfully performed, rated on remote video review
Time Frame
[ Time Frame: Time 0-30 min ]
Secondary Outcome Measure Information:
Title
Non technical skills performance
Description
As measured by the Ottawa score, rated on remote video review
Time Frame
[ Time Frame: Time 0-30 min ]

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Centre Lyonnais d'Enseignement par la Simulation en Santé
City
Lyon
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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