- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02678819
Use of a Wearable Digital Cognitive Aid in Simulated Anesthesia and Intensive Care Crises. (SIMMAX)
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.
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), easy to use with a manual validation of every simple step. Investigators seek to compare the technical and non technical management of these crises with and without this wearable cognitive aid.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Lyon, France, 69008
- Centre Lyonnais d'Enseignement par la Simulation en Santé
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Resident Physicians training in Anesthesia/Intensive care (same specialization in France), year 2 to 5 (out of 5)
Exclusion Criteria:
- All other residents, including Resident Physicians training in Anesthesia/Intensive care, year 1 (out of 5)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Digital Aid
The digital cognitive aid is designed as a smartphone app.
Intervention : cognitive aid during anesthesia and intensive care crises management.
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Digital cognitive aid during anesthesia and intensive care crises.
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NO_INTERVENTION: No digital aid
Anesthesia and intensive care crises managed without any cognitive aid.
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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 0-30 min
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Number of tasks successfully performed, rated on remote video review
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Time 0-30 min
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean-Christophe CEJKA, MD PhD mEng, Centre Lyonnais d'Enseignement par la Simulation en Santé, LYON
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SIMMAX UCBL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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