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

NCT ID: NCT02678819

Last Updated: 2016-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-04-30

Brief Summary

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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

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" 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.

Conditions

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Cognitive Aids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digital Aid

The digital cognitive aid is designed as a smartphone app. Intervention : cognitive aid during anesthesia and intensive care crises management.

Group Type EXPERIMENTAL

Digital cognitive aid

Intervention Type DEVICE

Digital cognitive aid during anesthesia and intensive care crises.

No digital aid

Anesthesia and intensive care crises managed without any cognitive aid.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Digital cognitive aid

Digital cognitive aid during anesthesia and intensive care crises.

Intervention Type DEVICE

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CEJKA Jean-Christophe

OTHER

Sponsor Role lead

Responsible Party

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CEJKA Jean-Christophe

MD PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jean-Christophe CEJKA, MD PhD mEng

Role: PRINCIPAL_INVESTIGATOR

Centre Lyonnais d'Enseignement par la Simulation en Santé, LYON

Locations

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Centre Lyonnais d'Enseignement par la Simulation en Santé

Lyon, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 29028930 (View on PubMed)

Other Identifiers

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SIMMAX UCBL

Identifier Type: -

Identifier Source: org_study_id

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