- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06491147
Increase Residents' Confidence in Emergency Front of Neck Access (eFONA).
A Simple Model to Increase Residents' Confidence in Emergency Front of Neck Access (eFONA).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Emergency front of neck access (eFONA) in a non-ventilated, non-oxygenated (CVCO) patient scenario is a life-saving and important competency for anesthesiologists to learn and even repeat intermittently. The Difficult Airway Society (DAS) guideline does not elaborate on how to conduct eFONA training, while the Canadian guideline states that successful performance of such rarely used skills requires regular practice in a simulation environment that focuses on technique and provides expert feedback. In this guideline, it was also mentioned that during training, procedures can be repeatedly performed in a simulate environment and interrupted for immediate feedback. In line with these recommendations, the investigators will create an easy, inexpensive, feasible and repeatable simulation-based learning environment in the operating room of the hospital. In this model study, it is aimed to teach the cricothyrotomy technique to anesthesiologists who have no experience in eFONA with an easy set up and to increase the confidence of the participants in this subject.
Participants will be divided into groups according to their duration of anesthesiology residency: 1st year, 2nd year, 3rd year, 4th and 5th year residents. A simple surgical airway delivery model will be created from the unused anesthesia circuit. The model will be described to the participants and anatomical markers will be explained: hyoid bone, thyroid cartilage, cricoid cartilage, cricothyroid membrane, tracheal rings. Then the algorithm in the DAS guidelines will be explained. Following this, the researcher will demonstrate the scalpel spark plug technique with a 4-step approach that is frequently used in skill teaching (4).
In step 1 of this approach, the technique will be demonstrated without any verbal explanation.
In the 2nd step, the technique will be demonstrated with verbal expression. In the 3rd step, the participant will be asked to have the trainer do it. In the 4th and last step, the participant will apply eFONA from start to finish.
Participants will apply all the steps on the model until they feel competent, then when the participants are ready, they will be asked to perform the technique by keeping a stopwatch. The stopwatch will be started when the participant takes the scalpel in his/her hand.
The circuit will be terminated when the balloon is inflated. In this way, a competitive learning environment will be created among the participants. Recorded values will be compared and minimum and maximum values will be determined. The participants will be asked the question "If you had to create an emergency FONA procedure, how long would it take you to open it?", the answers will be recorded and compared with the values after the research. Thus, it is aimed to increase the self-confidence of residents in eFONA.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: mehmet yilmaz
- Phone Number: +905052174432
- Email: drmyilmaz33@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Working as an assistant doctor in Kocaeli City Hospital Anesthesiology and Reanimation Clinic
Exclusion Criteria:
- Those who have previously received training on FONA
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1st year residency
|
The algorithm in the DAS manual will be explained. Following this, the researcher will demonstrate the scalpel spark plug technique with a 4-step approach that is frequently used in skill teaching. In step 1 of this approach, the technique will be demonstrated without any verbal explanation. In the 2nd step, the technique will be demonstrated with verbal expression. In the 3rd step, the participant will be asked to have the trainer do it. In the 4th and last step, the participant will apply eFONA from start to finish. |
|
2nd year residency
|
The algorithm in the DAS manual will be explained. Following this, the researcher will demonstrate the scalpel spark plug technique with a 4-step approach that is frequently used in skill teaching. In step 1 of this approach, the technique will be demonstrated without any verbal explanation. In the 2nd step, the technique will be demonstrated with verbal expression. In the 3rd step, the participant will be asked to have the trainer do it. In the 4th and last step, the participant will apply eFONA from start to finish. |
|
3rd year residency
|
The algorithm in the DAS manual will be explained. Following this, the researcher will demonstrate the scalpel spark plug technique with a 4-step approach that is frequently used in skill teaching. In step 1 of this approach, the technique will be demonstrated without any verbal explanation. In the 2nd step, the technique will be demonstrated with verbal expression. In the 3rd step, the participant will be asked to have the trainer do it. In the 4th and last step, the participant will apply eFONA from start to finish. |
|
4th year residency
|
The algorithm in the DAS manual will be explained. Following this, the researcher will demonstrate the scalpel spark plug technique with a 4-step approach that is frequently used in skill teaching. In step 1 of this approach, the technique will be demonstrated without any verbal explanation. In the 2nd step, the technique will be demonstrated with verbal expression. In the 3rd step, the participant will be asked to have the trainer do it. In the 4th and last step, the participant will apply eFONA from start to finish. |
|
5th year residency
|
The algorithm in the DAS manual will be explained. Following this, the researcher will demonstrate the scalpel spark plug technique with a 4-step approach that is frequently used in skill teaching. In step 1 of this approach, the technique will be demonstrated without any verbal explanation. In the 2nd step, the technique will be demonstrated with verbal expression. In the 3rd step, the participant will be asked to have the trainer do it. In the 4th and last step, the participant will apply eFONA from start to finish. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emergency front of neck access training practice on a model
Time Frame: 6 months
|
In this model study, it was aimed to teach the cricothyrotomy technique to anesthesiologists who had no experience in Emergency front of neck access (eFONA) and to increase the confidence of the participants in this subject.
The participants who participated in the research will be asked the question "If you need to create an emergency FONA procedure, how long would you open it?",
the answers will be recorded and compared with the values after the research.
Thus, it is aimed to increase the self-confidence of residents in eFONA.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mehmet Yilmaz, Kocaeli City Hospital Anesthesiology and Reanimation
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-48
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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