BehaviourPROSIDIAIRNCT02470195
Procedural Simulation for Difficult Airway Training in Anesthesiology Resident Education Program
A study testing workshop in people with Behaviour, run by Claude Bernard University at 1 site in France.
Trial summary
Difficult airway management is a crucial point that may influence outcomes of patient in this critical situation. Education for this topic is of main importance for resident of anesthesiology. Procedural simulation workshop allows participant to use device dedicated to difficult airway management. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Behaviour
- What is being tested?
- workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Jun 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Residents in 2nd year of anesthesiology residency in Rhones alpes auvergne and in Nîmes
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anesthesiology Education Implementation by Procedural Simulation Workshop for Difficult Airway Management: a Controlled Interregional French Study
Difficult airway management is a crucial point that may influence outcomes of patient in this critical situation. Education for this topic is of main importance for resident of anesthesiology. Procedural simulation workshop allows participant to use device dedicated to difficult airway management. Investigators included this workshop to a state education program of anesthesiology resident in second year and compared to their homonym in another state where no specific organized workshop is integrated to the education program.
Read the detailed description
Difficult airway management is a crucial point that may influence outcome of patient in this critical situation. Education for this topic is of main importance for resident of anesthesiology. Procedural simulation workshop allows participant to use device dedicated to difficult airway management. The investigators included this workshop for smal groups of 6-10 anesthesiology resident from Rhône Alpes Auvergne french state. Participants were ask to fill out a questionnaire about their specific knowledge and experience of several devices usable in difficult airway management situation. The workshop was a small briefing as an introduction to the workshop and then small workshop of 20-45 min for specific procedural use of different devices for difficult airway management : Eischmann guide, LMA, supraglottic devices, fiberoptic with spontaneous breathing, cricothyroidotomy, jet ventilation, percutaneous tracheotomy... Investigator will compare at 6 month the incidence of use of the difficult airway devices between resident from rhone alpes auvergne following the workshop and resident from Montpellier that did not follow specific organized workshop.
- Conditions
- Behaviour
- Being tested
- workshop
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
workshopBehavioural
workshop for procedural simulation for education in difficult airway situation
| Study group | Role | What they receive |
|---|---|---|
| workshop | Experimental | workshop of procedural simulation Receives: Behavioral: workshop |
| control | No intervention | no specific workshop of procedural simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of use of airway devices between groups
modification in the incidence of use of airway devices between workshop and control groups
Measured: 6 month
Secondary outcomes (1)
confidence with airway device
questionnaire of confidence with the usability of the devices. Scale from 0 to 10.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startNov 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BehaviourStudies of the same condition, open and under way.
- 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claude Bernard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilot Marc, Claude Bernard University
- Investigators
- marc Lilot, MD, Principal investigator, CLESS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470195
- Sponsor's protocol ID
- CLESS PROSIDIAIR 2014
- Acronym
- PROSIDIAIR
- Status last verified
- Jul 2016
- First submitted
- 28 May 2015
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: data will be analysed by group, no plan to share data has been programmed
Publications
Lilot M, Evain JN, Vincent A, Gaillard G, Chassard D, Mattatia L, Ripart J, Denoyel L, Bauer C, Robinson P, Duclos A, Lehot JJ, Rimmele T. [Simulation of difficult airway management for residents: prospective comparative study]. Braz J Anesthesiol. 2019 Jul-Aug;69(4):358-368. doi: 10.1016/j.bjan.2019.02.002. Epub 2019 Jul 29.
PubMed 31371173
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesiology Education Implementation by Procedural Simulation Workshop for Difficult Airway Management: a Controlled Interregional French Study
- ClinicalTrials.gov ID
- NCT02470195
- Acronym / sponsor ID
- PROSIDIAIR / CLESS PROSIDIAIR 2014
- Conditions
- Behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Claude Bernard UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 Jun 2015 (estimated)
- 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.
Difficult airway management is a crucial point that may influence outcomes of patient in this critical situation. Education for this topic is of main importance for resident of anesthesiology. Procedural simulation workshop allows participant to use device dedicated to difficult airway management. Investigators included this workshop to a state education program of anesthesiology resident in second year and compared to their homonym in another state where no specific organized workshop is integrated to the education program.
Detailed description
Difficult airway management is a crucial point that may influence outcome of patient in this critical situation. Education for this topic is of main importance for resident of anesthesiology. Procedural simulation workshop allows participant to use device dedicated to difficult airway management. The investigators included this workshop for smal groups of 6-10 anesthesiology resident from Rhône Alpes Auvergne french state. Participants were ask to fill out a questionnaire about their specific knowledge and experience of several devices usable in difficult airway management situation. The workshop was a small briefing as an introduction to the workshop and then small workshop of 20-45 min for specific procedural use of different devices for difficult airway management : Eischmann guide, LMA, supraglottic devices, fiberoptic with spontaneous breathing, cricothyroidotomy, jet ventilation, percutaneous tracheotomy... Investigator will compare at 6 month the incidence of use of the difficult airway devices between resident from rhone alpes auvergne following the workshop and resident from Montpellier that did not follow specific organized workshop.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| workshop | Experimental | Behavioral: workshopworkshop of procedural simulation |
| control | No intervention | –no specific workshop of procedural simulation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Residents in 2nd year of anesthesiology residency in Rhones alpes auvergne and in Nîmes
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 |
|---|---|---|
| workshopworkshop for procedural simulation for education in difficult airway situation | Behavioural | workshop |
Primary outcome
incidence of use of airway devices between groups
Time frame: 6 month
modification in the incidence of use of airway devices between workshop and control groups
1 secondary outcome
confidence with airway device
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Derived from this study: PubMed 31371173Lilot M, Evain JN, Vincent A, Gaillard G, Chassard D, Mattatia L, Ripart J, Denoyel L, Bauer C, Robinson P, Duclos A, Lehot JJ, Rimmele T. [Simulation of difficult airway management for residents: prospective comparative study]. Braz J Anesthesiol. 2019 Jul-Aug;69(4):358-368. doi: 10.1016/j.bjan.2019.02.002. Epub 2019 Jul 29.
- Individual participant dataSharing planned: No. data will be analysed by group, no plan to share data has been programmed
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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.
marc Lilot, MD principal investigator
CLESS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing workshop in people with Behaviour, run by Claude Bernard University 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 1 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: finished, as of the sponsor's last update on 7 Jul 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of use of airway devices between groups (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02470195, which also lists 1 linked publication.
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 7 Jul 2016.