NCT03474796

Brief Summary

The study aims to show a difference of observation and data integration between novice and expert during anaesthetic induction, in a population of nurse anesthetists.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 23, 2018

Status Verified

March 1, 2018

Enrollment Period

2 months

First QC Date

March 9, 2018

Last Update Submit

March 21, 2018

Conditions

Nurse's Role

Outcome Measures

Primary Outcomes (2)

  • Number of eye-fixations on each Region Of Interest (ROI)

    Measured with the eye-tracker

    Day 1

  • Duration of eye-fixation on each ROI

    Measured with the eye-tracker

    Day 1

Study Arms (2)

Novice

EXPERIMENTAL
Behavioral: Eye-tracking

Expert

EXPERIMENTAL
Behavioral: Eye-tracking

Interventions

Eye-trackingBEHAVIORAL

Visualisation of 4 photographic scenarios (surgical situations), questionnaire, eye-tracking

ExpertNovice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Groupe "novice" : nurse anesthetist students, in 1st or 2nd years at Besançon nursing school OR nurse anesthetists with less than 1 year experience at Besançon University Hospital
  • Group "expert" : full-time employed nurse anesthetists, with at least 5 years experience at Besançon University Hospital
  • Correct vision with or without correction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besancon

Besançon, France

Location

Study Officials

  • Magali Nicolier, PhD

    CHU DE BESANCON

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guilhot Ophelie

CONTACT

00336 87 15 71 05heliope.f@gmail.com

Vallet Myriam

CONTACT

00336 32 57 21 73vallet.myriam@neuf.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 23, 2018

Study Start

March 1, 2018

Primary Completion

May 1, 2018

Study Completion

June 1, 2018

Last Updated

March 23, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)