Clinical trial NCT06687395: Skill Retention of Advanced Airway Techniques After Simulation Training
Official title: Skill Retention of Advanced Airway Techniques After Simulation Training - a Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Educational Problems
Critical Incident
Emergencies
Airway Complication of Anesthesia
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: training model 1 - re-assessment model 1 Group 2: training model 2 - re-assessment model 1
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Non-inferiority of the training on the self-made model in terms of achieved checklist points
timeFrame: 3-4 months
Secondary outcomes:
measure: years of resideny and prior experience
timeFrame: 3-4 months
measure: time from the start of the procedure to the first successful ventilation
timeFrame: 3-4 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna
name: Bernhard Rössler, Prof.,MD,MIH
role: STUDY_DIRECTOR
References: