Unexpected Difficult AirwayNCT06491147
Increase Residents' Confidence in Emergency Front of Neck Access (eFONA).
An observational study of Unexpected Difficult Airway, run by Kocaeli City Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unexpected Difficult Airway
- What is being tested?
- Emergency front of neck access
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2024to 31 Dec 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: After obtaining participant consent, anesthesiology residents with no previous emergency FONA experience will be included in the study. Participants who do not give consent and have previous experience will be excluded from the study. Participants will be divided into groups according to their duration of anesthesiology residency: 1st year, 2nd year, 3rd year, 4th and 5th year residents.
Who may be able to join
- Working as an assistant doctor in Kocaeli City Hospital Anesthesiology and Reanimation Clinic
Who cannot join
- Those who have previously received training on FONA
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Simple Model to Increase Residents' Confidence in Emergency Front of Neck Access (eFONA).
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.
Read the 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.
- Conditions
- Unexpected Difficult Airway
- Being tested
- Emergency front of neck access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency front of neck accessOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1st year residency | Not described Receives: Other: Emergency front of neck access | |
| 2nd year residency | Not described Receives: Other: Emergency front of neck access | |
| 3rd year residency | Not described Receives: Other: Emergency front of neck access | |
| 4th year residency | Not described Receives: Other: Emergency front of neck access | |
| 5th year residency | Not described Receives: Other: Emergency front of neck access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency front of neck access training practice on a model
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start30 Jun 2024 (estimated)
- Primary completion21 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexpected Difficult AirwayStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- mehmet yilmaz, Principal investigator, Kocaeli City Hospital Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491147
- Sponsor's protocol ID
- 2024-48
- Status last verified
- Jul 2024
- First submitted
- 11 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simple Model to Increase Residents' Confidence in Emergency Front of Neck Access (eFONA).
- ClinicalTrials.gov ID
- NCT06491147
- Acronym / sponsor ID
- 2024-48
- Conditions
- Unexpected Difficult Airway
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 21 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Jul 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1st year residency | – | Other: Emergency front of neck access |
| 2nd year residency | – | Other: Emergency front of neck access |
| 3rd year residency | – | Other: Emergency front of neck access |
| 4th year residency | – | Other: Emergency front of neck access |
| 5th year residency | – | Other: Emergency front of neck access |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- After obtaining participant consent, anesthesiology residents with no previous emergency FONA experience will be included in the study. Participants who do not give consent and have previous experience will be excluded from the study. Participants will be divided into groups according to their duration of anesthesiology residency: 1st year, 2nd year, 3rd year, 4th and 5th year residents.
Key inclusion criteria (1 listed)
- Working as an assistant doctor in Kocaeli City Hospital Anesthesiology and Reanimation Clinic
Key exclusion criteria (1 listed)
- Those who have previously received training on FONA
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 |
|---|---|---|
| Emergency front of neck accessThe 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. | Other | 1st year residency, 2nd year residency, 3rd year residency, 4th year residency, 5th year residency |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
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.
mehmet yilmaz principal investigator
Kocaeli City Hospital Anesthesiology and Reanimation
Questions about this trial
What is this clinical trial studying?
An observational study of Unexpected Difficult Airway, run by Kocaeli City Hospital.
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 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: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mehmet yilmaz (+905052174432, drmyilmaz33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency front of neck access training practice on a model (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2024.