Educational ProblemsNCT06687395
Skill Retention of Advanced Airway Techniques After Simulation Training
A study testing Skill training on different models in people with Educational Problems and Critical Incident, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Background: FONA (front of neck access) is a surgical airway management technique used in emergency situations, primarily as the "last option" when less invasive airway management methods have failed. The need for FONA is extremely rare, which makes regular training in this skill all the more important. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Educational Problems, Critical Incident, Emergencies
- What is being tested?
- Skill training on different models
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteAustria
- Study dates
- 2 Dec 2024to 30 Jun 2025
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Resident physicians at the Medical University of Vienna (Department of Anaesthesia, Intensive Care Medicine and Pain Medicine)
- Presence of written consent
Who cannot join
- Prior clinical experience in 'front of neck access' with more than five performed cricothyrotomies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Skill Retention of Advanced Airway Techniques After Simulation Training - a Randomized Prospective Study
Background: FONA (front of neck access) is a surgical airway management technique used in emergency situations, primarily as the "last option" when less invasive airway management methods have failed. The need for FONA is extremely rare, which makes regular training in this skill all the more important.
Study Objective: The objective of this study is to test "skill retention" three to four months after training on different cricothyrotomy models. The goal is to demonstrate that there is no intolerable difference in skill retention, regardless of whether FONA training is conducted on a commercially available cricothyrotomy model or on a self-made model.
Read more
Population: The study population consists of 42 participants who are randomly assigned to two groups.
Study Design: All participants begin with the same theoretical input. Following this, they complete training on their assigned practice model before undergoing an initial evaluation. Three to four months after the first evaluation, a reevaluation takes place, this time without any prior training.
Parameters: The primary outcome parameter of the study is the score achieved on the checklist. Secondary outcome parameters include the time from the start of the procedure to the first successful ventilation and subjective assessment using a Likert scale questionnaire. Possible associations between checklist results and factors such as year of training, prior experience, clinical experience, and individual items on the subjective assessment questionnaire will be presented graphically in an exploratory manner and quantified using appropriate correlation coefficients.
Hypothesis: The study aims to show that there is no intolerable difference in skill retention, regardless of whether FONA training takes place on a commercially available cricothyrotomy model or on a self-made model. This would open up the possibility of using cost-effective and readily accessible practice models for effective skill training.
Read the detailed description
The study is a prospective, randomized assessment of the skill retention following a FONA (front of neck access) training. A randomized allocation is conducted, dividing participants into two groups of 21 resident physicians each from the Medical University of Vienna, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine. The two groups train on two different practice models: a commercially available cricothyrotomy model (SimMan 3G, Laerdal Medical) and a self-made model based on instructions by Varaday et al. The skill retention reevaluation after three to four months takes place for all participants on the SimMan 3G.
The study begins in both groups with an identical theoretical introduction and training of FONA. Following this, all participants are given the same practice time on the model assigned to their group, before undergoing an initial evaluation. Three to four months after the initial training session and evaluation, a reevaluation is conducted in which both groups perform FONA on the SimMan 3G. The reevaluation analysis serves as the primary goal of the study, aimed at investigating the non-inferiority of the self-made model. The SimMan 3G by Laerdal was selected as it is a widely used practice model and has been described in previous studies with medium to high fidelity.
The evaluation is conducted in the form of a checklist (Difficult Airway Society), which provides a point system allowing conclusions about skill retention. Additionally, the time taken from the start to the first successful ventilation is documented and analyzed in the study as a secondary measure. After each evaluation, participants complete a questionnaire in the form of a Likert scale to assess subjective factors.
- Being tested
- Skill training on different models
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skill training on different modelsOther
Skill training on different models (medium/high fidelity vs. self-made model)
| Study group | Role | What they receive |
|---|---|---|
| medium/high fidelity model | Other | Group 1: training model 1 - re-assessment model 1 Receives: Other: Skill training on different models |
| self-made model | Other | Group 2: training model 2 - re-assessment model 1 Receives: Other: Skill training on different models |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of the training on the self-made model in terms of achieved checklist points
checklist points (0-19)
Measured: 3-4 months
Secondary outcomes (2)
years of resideny and prior experience
- years of residency (years) / 2) prior experience with front of neck access in skill trainings (number) / 3) number of performed front of neck accesses in clinical practice (number)
Measured: 3-4 months
time from the start of the procedure to the first successful ventilation
measured in seconds
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start2 Dec 2024
- Primary completion30 Mar 2025
- Study completion30 Jun 2025
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 Educational ProblemsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: training model 1 - re-assessment model 1 Group 2: training model 2 - re-assessment model 1
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Holaubek, MD, Medical University of Vienna
- Investigators
- Bernhard Rössler, Prof.,MD,MIH, Study director, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687395
- Sponsor's protocol ID
- EK Nr: 1518/2024
- Status last verified
- Sep 2025
- First submitted
- 5 Nov 2024
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to an ongoing Master thesis the dataset is not available at the moment
Publications
Stochlinski C, Maleczek M, Korn L, Gleiss A, Breckwoldt J, Roessler B. Skill retention of advanced airway techniques after simulation training - a randomized prospective study. BMC Med Educ. 2026 Jan 28;26(1):325. doi: 10.1186/s12909-026-08646-5.
PubMed 41606573
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skill Retention of Advanced Airway Techniques After Simulation Training - a Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT06687395
- Acronym / sponsor ID
- EK Nr: 1518/2024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 13 Nov 2024 (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.
Background: FONA (front of neck access) is a surgical airway management technique used in emergency situations, primarily as the "last option" when less invasive airway management methods have failed. The need for FONA is extremely rare, which makes regular training in this skill all the more important.
Study Objective: The objective of this study is to test "skill retention" three to four months after training on different cricothyrotomy models. The goal is to demonstrate that there is no intolerable difference in skill retention, regardless of whether FONA training is conducted on a commercially available cricothyrotomy model or on a self-made model.
Population: The study population consists of 42 participants who are randomly assigned to two groups.
Study Design: All participants begin with the same theoretical input. Following this, they complete training on their assigned practice model before undergoing an initial evaluation. Three to four months after the first evaluation, a reevaluation takes place, this time without any prior training.
Parameters: The primary outcome parameter of the study is the score achieved on the checklist. Secondary outcome parameters include the time from the start of the procedure to the first successful ventilation and subjective assessment using a Likert scale questionnaire. Possible associations between checklist results and factors such as year of training, prior experience, clinical experience, and individual items on the subjective assessment questionnaire will be presented graphically in an exploratory manner and quantified using appropriate correlation coefficients.
Hypothesis: The study aims to show that there is no intolerable difference in skill retention, regardless of whether FONA training takes place on a commercially available cricothyrotomy model or on a self-made model. This would open up the possibility of using cost-effective and readily accessible practice models for effective skill training.
Detailed description
The study is a prospective, randomized assessment of the skill retention following a FONA (front of neck access) training. A randomized allocation is conducted, dividing participants into two groups of 21 resident physicians each from the Medical University of Vienna, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine. The two groups train on two different practice models: a commercially available cricothyrotomy model (SimMan 3G, Laerdal Medical) and a self-made model based on instructions by Varaday et al. The skill retention reevaluation after three to four months takes place for all participants on the SimMan 3G.
The study begins in both groups with an identical theoretical introduction and training of FONA. Following this, all participants are given the same practice time on the model assigned to their group, before undergoing an initial evaluation. Three to four months after the initial training session and evaluation, a reevaluation is conducted in which both groups perform FONA on the SimMan 3G. The reevaluation analysis serves as the primary goal of the study, aimed at investigating the non-inferiority of the self-made model. The SimMan 3G by Laerdal was selected as it is a widely used practice model and has been described in previous studies with medium to high fidelity.
The evaluation is conducted in the form of a checklist (Difficult Airway Society), which provides a point system allowing conclusions about skill retention. Additionally, the time taken from the start to the first successful ventilation is documented and analyzed in the study as a secondary measure. After each evaluation, participants complete a questionnaire in the form of a Likert scale to assess subjective factors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1: training model 1 - re-assessment model 1 Group 2: training model 2 - re-assessment model 1
| Arm | Type | Receives |
|---|---|---|
| medium/high fidelity model | Other | Other: Skill training on different modelsGroup 1: training model 1 - re-assessment model 1 |
| self-made model | Other | Other: Skill training on different modelsGroup 2: training model 2 - re-assessment model 1 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Resident physicians at the Medical University of Vienna (Department of Anaesthesia, Intensive Care Medicine and Pain Medicine)
- Presence of written consent
Key exclusion criteria (1 listed)
- Prior clinical experience in 'front of neck access' with more than five performed cricothyrotomies
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 |
|---|---|---|
| Skill training on different modelsSkill training on different models (medium/high fidelity vs. self-made model) | Other | medium/high fidelity model, self-made model |
Primary outcome
Non-inferiority of the training on the self-made model in terms of achieved checklist points
Time frame: 3-4 months
checklist points (0-19)
2 secondary outcomes
years of resideny and prior experience
Time frame: 3-4 months
time from the start of the procedure to the first successful ventilation
Time frame: 3-4 months
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 23 Sep 2025.
- Derived from this study: PubMed 41606573Stochlinski C, Maleczek M, Korn L, Gleiss A, Breckwoldt J, Roessler B. Skill retention of advanced airway techniques after simulation training - a randomized prospective study. BMC Med Educ. 2026 Jan 28;26(1):325. doi: 10.1186/s12909-026-08646-5.
- Individual participant dataSharing planned: No. Due to an ongoing Master thesis the dataset is not available at the moment
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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.
Bernhard Rössler, Prof.,MD,MIH study director
Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skill training on different models in people with Educational Problems and Critical Incident, run by Medical University of Vienna at 1 site in Austria.
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 2 inclusion and 1 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 23 Sep 2025. 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 Austria. 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?
Non-inferiority of the training on the self-made model in terms of achieved checklist points (time frame: 3-4 months). 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 NCT06687395, 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 23 Sep 2025.