NCT06687395

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 13, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

December 2, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

November 5, 2024

Last Update Submit

September 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Non-inferiority of the training on the self-made model in terms of achieved checklist points

    checklist points (0-19)

    3-4 months

Secondary Outcomes (2)

  • years of resideny and prior experience

    3-4 months

  • time from the start of the procedure to the first successful ventilation

    3-4 months

Study Arms (2)

medium/high fidelity model

OTHER

Group 1: training model 1 - re-assessment model 1

Other: Skill training on different models

self-made model

OTHER

Group 2: training model 2 - re-assessment model 1

Other: Skill training on different models

Interventions

Skill training on different models (medium/high fidelity vs. self-made model)

medium/high fidelity modelself-made model

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Resident physicians at the Medical University of Vienna (Department of Anaesthesia, Intensive Care Medicine and Pain Medicine)
  • Presence of written consent

You may not qualify if:

  • Prior clinical experience in 'front of neck access' with more than five performed cricothyrotomies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

  • 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. doi: 10.1186/s12909-026-08646-5. Online ahead of print.

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bernhard Rössler, Prof.,MD,MIH

    Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
pseudonymized
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Group 1: training model 1 - re-assessment model 1 Group 2: training model 2 - re-assessment model 1
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 5, 2024

First Posted

November 13, 2024

Study Start

December 2, 2024

Primary Completion

March 30, 2025

Study Completion

June 30, 2025

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Due to an ongoing Master thesis the dataset is not available at the moment

Locations