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

July 25, 2016 updated by: CEJKA Jean-Christophe
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.

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
Number of tasks successfully performed, rated on remote video review
Time 0-30 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CEJKA Jean-Christophe

Investigators

  • Principal Investigator: Jean-Christophe CEJKA, MD PhD mEng, Centre Lyonnais d'Enseignement par la Simulation en Santé, LYON

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

February 5, 2016

First Posted (ESTIMATE)

February 10, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

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)?

NO

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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