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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 4, 2016
First Posted Date  ICMJE February 10, 2016
Last Update Posted Date July 26, 2016
Study Start Date  ICMJE July 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of a Wearable Digital Cognitive Aid in Simulated Anesthesia and Intensive Care Crises.
Official Title  ICMJE Use of a Wearable Digital Cognitive Aid in Simulated Anesthesia and Intensive Care Crises.
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cognitive Aids
Intervention  ICMJE Device: Digital cognitive aid
Digital cognitive aid during anesthesia and intensive care crises.
Study Arms  ICMJE
  • Experimental: Digital Aid
    The digital cognitive aid is designed as a smartphone app. Intervention : cognitive aid during anesthesia and intensive care crises management.
    Intervention: Device: Digital cognitive aid
  • No Intervention: No digital aid
    Anesthesia and intensive care crises managed without any cognitive aid.
Publications * Lelaidier R, Balança B, Boet S, Faure A, Lilot M, Lecomte F, Lehot JJ, Rimmelé T, Cejka JC. Use of a hand-held digital cognitive aid in simulated crises: the MAX randomized controlled trial. Br J Anaesth. 2017 Nov 1;119(5):1015-1021. doi: 10.1093/bja/aex256.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2016)
52
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2016)
50
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02678819
Other Study ID Numbers  ICMJE SIMMAX UCBL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CEJKA Jean-Christophe, Claude Bernard University
Study Sponsor  ICMJE CEJKA Jean-Christophe
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Christophe CEJKA, MD PhD mEng Centre Lyonnais d'Enseignement par la Simulation en Santé, LYON
PRS Account Claude Bernard University
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP