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Use of a Wearable Digital Cognitive Aid in Simulated Anesthesia and Intensive Care Crises. (SIMMAX)

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ClinicalTrials.gov Identifier: NCT02678819
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
CEJKA Jean-Christophe, Claude Bernard University

Brief Summary:
The purpose of this study is to determine whether a wearable digital cognitive aid has an effect in the management of simulated crises in anesthesia or intensive care.

Condition or disease Intervention/treatment Phase
Cognitive Aids Device: Digital cognitive aid 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.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of a Wearable Digital Cognitive Aid in Simulated Anesthesia and Intensive Care Crises.
Study Start Date : July 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

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.
Device: Digital cognitive aid
Digital cognitive aid during anesthesia and intensive care crises.

No Intervention: No digital aid
Anesthesia and intensive care crises managed without any cognitive aid.



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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT02678819


Locations
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France
Centre Lyonnais d'Enseignement par la Simulation en Santé
Lyon, France, 69008
Sponsors and Collaborators
CEJKA Jean-Christophe
Investigators
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Principal Investigator: Jean-Christophe CEJKA, MD PhD mEng Centre Lyonnais d'Enseignement par la Simulation en Santé, LYON
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: CEJKA Jean-Christophe, MD PhD, Claude Bernard University
ClinicalTrials.gov Identifier: NCT02678819    
Other Study ID Numbers: SIMMAX UCBL
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No