NCT02678819

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

8 months

First QC Date

February 4, 2016

Last Update Submit

July 25, 2016

Conditions

Cognitive Aids

Outcome Measures

Primary Outcomes (1)

  • Technical Performance as compared to a Reference Task List

    Number of tasks successfully performed, rated on remote video review

    Time 0-30 min

Study Arms (2)

Digital Aid

EXPERIMENTAL

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 digital aid

NO INTERVENTION

Anesthesia and intensive care crises managed without any cognitive aid.

Interventions

Digital cognitive aidDEVICE

Digital cognitive aid during anesthesia and intensive care crises.

Digital Aid

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Lyonnais d'Enseignement par la Simulation en Santé

Lyon, 69008, France

Location

Related Publications (1)

  • 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.

    PMID: 29028930DERIVED

Study Officials

  • Jean-Christophe CEJKA, MD PhD mEng

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

February 4, 2016

First Posted

February 10, 2016

Study Start

July 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

July 26, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)