NCT03253770

Brief Summary

Cardiac arrest is one of the most stressful situations to be managed. Our first study (MAX, accepted for publication BJA) clearly showed that it could not be compared to other urgent and stressful situations (malignant hyperthermia, anaphylactic shock, acute toxicity of local anesthetics, severe and symptomatic hyperkaliemia) whose management was significantly improved with the help of a digital cognitive aid. The present study exclusively deals with the management of cardiac arrest (recovery ward, or in the delivery room.) with the second generation of our digital cognitive aid, and explores new insights on how to better manage cardiac arrest with a digital cognitive aid in the hand of the leader.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

3 months

First QC Date

August 16, 2017

Last Update Submit

August 17, 2017

Conditions

Keywords

Cognitive Aid

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 Frame: Time 0-30 min ]

Secondary Outcomes (1)

  • Non technical skills performance

    [ Time Frame: Time 0-30 min ]

Study Arms (3)

Digital Cognitive Aid

EXPERIMENTAL

The digital cognitive aid is designed as a smartphone app. Intervention : cognitive aid in the hand of the leader during crises management.

Device: SIMMAX2

No digital aid

EXPERIMENTAL

No cognitive aid in the hand of the leader during crises management. Intervention : no cognitive aid in the hand of the leader during crises management.

Device: SIMMAX2

Paper Cognitive Aid

EXPERIMENTAL

The paper cognitive aid is the document officially recommended to be used in case of crises by the French Society of Anaesthesia and Intensive Care. Intervention : paper cognitive aid in the hand of the leader during crises management.

Device: SIMMAX2

Interventions

SIMMAX2DEVICE

Digital cognitive aid or paper cognitive aid during the management of a cardiac arrest in the recovery room or in the delivery room.

Digital Cognitive AidNo digital aidPaper Cognitive Aid

Eligibility Criteria

Sexall
Healthy VolunteersYes
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 1 to 5 (out of 5)
  • to be familiar with our simulation centre (at least passed once as a resident)

You may not qualify if:

  • no experience in simulation training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Lyonnais d'Enseignement par la Simulation en Santé

Lyon, France

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, MEng

Study Record Dates

First Submitted

August 16, 2017

First Posted

August 18, 2017

Study Start

May 1, 2017

Primary Completion

August 1, 2017

Study Completion

August 16, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations