Clinical Observation During Anaesthetic Induction: Which... | NCT03474796

Studies
Clinical Observation During Anaesthetic Induction: Which Difference Between Novice and Expert ?

NCT03474796

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Unknown status

Last Update Posted

Mar 23, 2018Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Nurse's Role

Interventions

Eye-tracking

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2018Estimated

Primary Completion Date

May 2018Estimated

Completion Date

Jun 2018Estimated

First Submitted Date

Mar 9, 2018

First Submission Date that Met QC Criteria

Mar 21, 2018

First Posted Date

Mar 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2018

Last Update Posted Date

Mar 23, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Novice	Experimental		Behavioral: Eye-tracking
Expert	Experimental		Behavioral: Eye-tracking

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eye-tracking	Behavioral	Visualisation of 4 photographic scenarios (surgical situations), questionnaire, eye-tracking	Expert Novice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Guilhot Ophelie	Contact	00336 87 15 71 05		heliope.f@gmail.com
Vallet Myriam	Contact	00336 32 57 21 73		vallet.myriam@neuf.fr

Overall Officials

Name	Affiliation	Role
Magali Nicolier, PhD	CHU DE BESANCON	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Besancon		Besançon			France	Guilhot Ophélie

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided