Nurse's RoleOCCIANCT03474796
Clinical Observation During Anaesthetic Induction: Which Difference Between Novice and Expert ?
A study testing Eye-tracking in people with Nurse's Role, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role
- What is being tested?
- Eye-tracking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2018to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Besancon
Besançon
Guilhot Ophélie, heliope.f@gmail.com
Vallet Myriam, vallet.myriam@neuf.fr
About this study
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.
- Conditions
- Nurse's Role
- Being tested
- Eye-tracking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye-trackingBehavioural
Visualisation of 4 photographic scenarios (surgical situations), questionnaire, eye-tracking
| Study group | Role | What they receive |
|---|---|---|
| Novice | Experimental | Not described Receives: Behavioral: Eye-tracking |
| Expert | Experimental | Not described Receives: Behavioral: Eye-tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of eye-fixations on each Region Of Interest (ROI)
Measured with the eye-tracker
Measured: Day 1
Duration of eye-fixation on each ROI
Measured with the eye-tracker
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study startMar 2018 (estimated)
- Primary completionMay 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magali Nicolier, PhD, Principal investigator, CHU DE BESANCON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474796
- Sponsor's protocol ID
- P/2018/361
- Acronym
- OCCIA
- Status last verified
- Mar 2018
- First submitted
- 9 Mar 2018
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation During Anaesthetic Induction: Which Difference Between Novice and Expert ?
- ClinicalTrials.gov ID
- NCT03474796
- Acronym / sponsor ID
- OCCIA / P/2018/361
- Conditions
- Nurse's Role
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- May 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novice | Experimental | Behavioral: Eye-tracking |
| Expert | Experimental | Behavioral: Eye-tracking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye-trackingVisualisation of 4 photographic scenarios (surgical situations), questionnaire, eye-tracking | Behavioural | Expert, Novice |
Primary outcome
Number of eye-fixations on each Region Of Interest (ROI)
Time frame: Day 1
Measured with the eye-tracker
Duration of eye-fixation on each ROI
Time frame: Day 1
Measured with the eye-tracker
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magali Nicolier, PhD principal investigator
CHU DE BESANCON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye-tracking in people with Nurse's Role, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guilhot Ophelie (00336 87 15 71 05, heliope.f@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of eye-fixations on each Region Of Interest (ROI) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.