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CompletedNCT02678819SIMMAXUpdated Jul 26, 2016

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

An interventional study of Digital cognitive aid in Cognitive Aids, sponsored by CEJKA Jean-Christophe. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2016-07-26.

Sponsored by CEJKA Jean-Christophe · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cognitive Aids
03

In context

Lead sponsor

CEJKA Jean-Christophe is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Resident Physicians training in Anesthesia/Intensive care (same specialization in France), year 2 to 5 (out of 5)

Exclusion criteria

Exclusion Criteria:

  • All other residents, including Resident Physicians training in Anesthesia/Intensive care, year 1 (out of 5)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • 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

  • No intervention
    No digital aid

    Anesthesia and intensive care crises managed without any cognitive aid.

Interventions

  • DeviceDigital cognitive aid

    Digital cognitive aid during anesthesia and intensive care crises.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Centre Lyonnais d'Enseignement par la Simulation en Santé
    Lyon, 69008, France
08

References and documents

Publications

  • Lelaidier R, Balanca B, Boet S, Faure A, Lilot M, Lecomte F, Lehot JJ, Rimmele 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. PubMed 29028930 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02678819
Lead sponsor
CEJKA Jean-Christophe
Responsible party
CEJKA Jean-Christophe (MD PhD, Claude Bernard University) — Sponsor-investigator
First posted
Feb 10, 2016
Start date
Jul 2015
Primary completion
Mar 2016
Completion
Apr 2016
Last update
Jul 26, 2016

Study contacts

Jean-Christophe CEJKA, MD PhD mEng
principal investigator · Centre Lyonnais d'Enseignement par la Simulation en Santé, LYON

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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