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

Cognitive Aids Clinical Trial

— SIMMAX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02678819
• Other study ID #: SIMMAX UCBL
• Status: Completed
• Phase: N/A
• First received: February 4, 2016
• Last updated: July 25, 2016
• Start date: July 2015
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: Claude Bernard University
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognitive Aids

Intervention

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

Locations

Country	Name	City	State
France	Centre Lyonnais d'Enseignement par la Simulation en Santé	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
CEJKA Jean-Christophe

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical Performance as compared to a Reference Task List	Number of tasks successfully performed, rated on remote video review	Time 0-30 min	No