Emergency Medical ServicesERAD-ESANCT06645288
The Evaluation of Training an Emergency Reflex Action Drill in the Emergency Surgical Airway in Dutch Paramedics
An observational study of Emergency Medical Services and Airway Management, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The goal of this observational study is to learn about the effects of training an Emergency Reflex Action Drill (ERAD) for Emergency Surgical Airway (ESA) in Dutch paramedics. The main question it aims to answer is: Does training an ERAD improves self-confidence in performing an ESA in Dutch paramedics Participants… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Emergency Medical Services, Airway Management, Cricothyroidotomy
- What is being tested?
- Emergency Reflex Action Drill
- How many people
- 84 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Sep 2024to 30 Mar 2026
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: The study will include Dutch paramedics attending a course. Dutch paramedics are all registered nurses with a background in Intensive Care, Anaesthesiology or Emergency Care. EMS training comprises an additional nine months of training and assessments, to be concluded with a final exam. Also, ambulance drivers of ambulances providing advanced life support (excluding medium care ambulances) who participate in the course are eligible to participate due to their supporting role in airway management.
Who may be able to join
- Registered Dutch paramedic
- Ambulance driver on Advanced Life Support Ambulance
- Participant in the two-day trauma course.
Who cannot join
- Medium care ambulance paramedic
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academie van Ambulancezorg
Harderwijk, Gelderland, 3847 LG
About this study
Official title: The Use of an Emergency Reflex Action Drill in Emergency Surgical Airway
The goal of this observational study is to learn about the effects of training an Emergency Reflex Action Drill (ERAD) for Emergency Surgical Airway (ESA) in Dutch paramedics. The main question it aims to answer is:
- Does training an ERAD improves self-confidence in performing an ESA in Dutch paramedics Participants will fill out a questionnaire directly before and after the training. To investigate long-term effects, they will be asked to fill out a questionnaire after 2 till 3 months and after one year.
- Conditions
- Emergency Medical Services, Airway Management, Cricothyroidotomy, Prehospital, Prehospital Emergency Medical Services, Prehospital Setting
- Being tested
- Emergency Reflex Action Drill
- Keywords
- Emergency Reflex Action Drill, Emergency Surgical Airway, Emergency Medical Services, Prehospital, Cricothyrotomy, Coniotomy, Porcine model, 3D model, Self-confidence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Reflex Action DrillOther
Emergency Reflex Action Drill in performing Emergency Surgical Airway
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-confidence
Increase/decrease/no difference in self-confidence from baseline, assessed by a five-point Likert-scale of paramedics in performing an Emergency Surgical Airway
Measured: Baseline, pre-training up to immediately after the training
Secondary outcomes (2)
Training model
Difference in effect on self-confidence between two training models used during the ESA-ERAD training, assessed by a five-point Likert-scale.
Measured: Immediately after the training
Self-confidence real life cases
Increase/decrease/no difference in self-confidence assessed by a five-point Likert-scale and correctly placed emergency surgical airway in real-life cases reported by paramedics at any time point after the ESA-ERAD training, up to an average of 1 year
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start9 Sep 2024
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Emergency Medical ServicesStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iscander M Maissan, Erasmus Medical Center
- Investigators
- Iscander M Maissan, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645288
- Sponsor's protocol ID
- MEC-2024-0388
- Acronym
- ERAD-ESA
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Unver V, Basak T, Watts P, Gaioso V, Moss J, Tastan S, Iyigun E, Tosun N. The reliability and validity of three questionnaires: The Student Satisfaction and Self-Confidence in Learning Scale, Simulation Design Scale, and Educational Practices Questionnaire. Contemp Nurse. 2017 Feb;53(1):60-74. doi: 10.1080/10376178.2017.1282319. Epub 2017 Feb 10.
PubMed 28084900Armstrong L, Harding F, Critchley J, McNarry AF, Myatra SN, Cooper R, Baker PA; World Airway Management Meeting 2015 Education Group. An international survey of airway management education in 61 countriesdagger. Br J Anaesth. 2020 Jul;125(1):e54-e60. doi: 10.1016/j.bja.2020.04.051. Epub 2020 May 20.
PubMed 32444066Iverson K, Riojas R, Sharon D, Hall AB. Objective comparison of animal training versus artificial simulation for initial cricothyroidotomy training. Am Surg. 2015 May;81(5):515-8.
PubMed 25975338Gustafson ML, Hensley B, Dotson M, Broce M, Tager A. Comparison of Manikin Versus Porcine Trachea Models When Teaching Emergent Cricothyroidotomy Among Emergency Medicine Residents. AEM Educ Train. 2019 Apr 7;3(3):280-285. doi: 10.1002/aet2.10333. eCollection 2019 Jul.
PubMed 31360821Cho J, Kang GH, Kim EC, Oh YM, Choi HJ, Im TH, Yang JH, Cho YS, Chung HS. Comparison of manikin versus porcine models in cricothyrotomy procedure training. Emerg Med J. 2008 Nov;25(11):732-4. doi: 10.1136/emj.2008.059014.
PubMed 18955605Warren JN, Luctkar-Flude M, Godfrey C, Lukewich J. A systematic review of the effectiveness of simulation-based education on satisfaction and learning outcomes in nurse practitioner programs. Nurse Educ Today. 2016 Nov;46:99-108. doi: 10.1016/j.nedt.2016.08.023. Epub 2016 Aug 25.
PubMed 27621199Jabaay MJ, Marotta DA, Aita SL, Walker DB, Grcevich LO, Camba V, Nolin JR, Lyons J, Giannini J Jr. Medical Simulation-Based Learning Outcomes in Pre-Clinical Medical Education. Cureus. 2020 Dec 3;12(12):e11875. doi: 10.7759/cureus.11875.
PubMed 33415028Chan CH, Chan TN, Yuen MC, Tung WK. Evaluation of a simulation-based workshop on clinical performance for emergency physicians and nurses. World J Emerg Med. 2015;6(1):16-22. doi: 10.5847/wjem.j.1920-8642.2015.01.003.
PubMed 25802561Morton S, Avery P, Kua J, O'Meara M. Success rate of prehospital emergency front-of-neck access (FONA): a systematic review and meta-analysis. Br J Anaesth. 2023 May;130(5):636-644. doi: 10.1016/j.bja.2023.01.022. Epub 2023 Feb 28.
PubMed 36858888Zink N, Merelman A, Fisher AD, Lauria MJ. Emergency Reflex Action Drills and the Problem with Stress. J Spec Oper Med. 2023 Mar 15;23(1):54-58. doi: 10.55460/RCF2-CXS9.
PubMed 36764288Smith JE, Rickard A, Wise D. Traumatic cardiac arrest. J R Soc Med. 2015 Jan;108(1):11-6. doi: 10.1177/0141076814560837.
PubMed 25572990Burns KJ, Robinson K, Lowe EG. Evaluation of responses of an air medical helicopter program during a comprehensive emergency response drill. Air Med J. 2007 May-Jun;26(3):139-43. doi: 10.1016/j.amj.2006.08.009.
PubMed 17467567Anderson NE, Gott M, Slark J. Beyond prognostication: ambulance personnel's lived experiences of cardiac arrest decision-making. Emerg Med J. 2018 Apr;35(4):208-213. doi: 10.1136/emermed-2017-206743. Epub 2018 Jan 5.
PubMed 29305380Chrimes N. The Vortex: a universal 'high-acuity implementation tool' for emergency airway management. Br J Anaesth. 2016 Sep;117 Suppl 1:i20-i27. doi: 10.1093/bja/aew175. Epub 2016 Jul 20.
PubMed 27440673Reardon RF, Robinson AE, Kornas R, Ho JD, Anzalone B, Carlson J, Levy M, Driver B. Prehospital Surgical Airway Management: An NAEMSP Position Statement and Resource Document. Prehosp Emerg Care. 2022;26(sup1):96-101. doi: 10.1080/10903127.2021.1995552.
PubMed 35001821
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of an Emergency Reflex Action Drill in Emergency Surgical Airway
- ClinicalTrials.gov ID
- NCT06645288
- Acronym / sponsor ID
- ERAD-ESA / MEC-2024-0388
- Conditions
- Emergency Medical Services, Airway Management, Cricothyroidotomy, Prehospital, Prehospital Emergency Medical Services, Prehospital Setting
- Keywords
- Emergency Reflex Action Drill, Emergency Surgical Airway, Emergency Medical Services, Prehospital, Cricothyrotomy, Coniotomy, Porcine model, 3D model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 16 Oct 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.
The goal of this observational study is to learn about the effects of training an Emergency Reflex Action Drill (ERAD) for Emergency Surgical Airway (ESA) in Dutch paramedics. The main question it aims to answer is:
- Does training an ERAD improves self-confidence in performing an ESA in Dutch paramedics Participants will fill out a questionnaire directly before and after the training. To investigate long-term effects, they will be asked to fill out a questionnaire after 2 till 3 months and after one year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include Dutch paramedics attending a course. Dutch paramedics are all registered nurses with a background in Intensive Care, Anaesthesiology or Emergency Care. EMS training comprises an additional nine months of training and assessments, to be concluded with a final exam. Also, ambulance drivers of ambulances providing advanced life support (excluding medium care ambulances) who participate in the course are eligible to participate due to their supporting role in airway management.
Key inclusion criteria (3 listed)
- Registered Dutch paramedic
- Ambulance driver on Advanced Life Support Ambulance
- Participant in the two-day trauma course.
Key exclusion criteria (1 listed)
- Medium care ambulance paramedic
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 Reflex Action DrillEmergency Reflex Action Drill in performing Emergency Surgical Airway | Other | – |
Primary outcome
Self-confidence
Time frame: Baseline, pre-training up to immediately after the training
Increase/decrease/no difference in self-confidence from baseline, assessed by a five-point Likert-scale of paramedics in performing an Emergency Surgical Airway
2 secondary outcomes
Training model
Time frame: Immediately after the training
Self-confidence real life cases
Time frame: Through study completion, an average of 1 year
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 6 Apr 2026.
- Background: PubMed 28084900Unver V, Basak T, Watts P, Gaioso V, Moss J, Tastan S, Iyigun E, Tosun N. The reliability and validity of three questionnaires: The Student Satisfaction and Self-Confidence in Learning Scale, Simulation Design Scale, and Educational Practices Questionnaire. Contemp Nurse. 2017 Feb;53(1):60-74. doi: 10.1080/10376178.2017.1282319. Epub 2017 Feb 10.
- Background: PubMed 32444066Armstrong L, Harding F, Critchley J, McNarry AF, Myatra SN, Cooper R, Baker PA; World Airway Management Meeting 2015 Education Group. An international survey of airway management education in 61 countriesdagger. Br J Anaesth. 2020 Jul;125(1):e54-e60. doi: 10.1016/j.bja.2020.04.051. Epub 2020 May 20.
- Background: PubMed 25975338Iverson K, Riojas R, Sharon D, Hall AB. Objective comparison of animal training versus artificial simulation for initial cricothyroidotomy training. Am Surg. 2015 May;81(5):515-8.
- Background: PubMed 31360821Gustafson ML, Hensley B, Dotson M, Broce M, Tager A. Comparison of Manikin Versus Porcine Trachea Models When Teaching Emergent Cricothyroidotomy Among Emergency Medicine Residents. AEM Educ Train. 2019 Apr 7;3(3):280-285. doi: 10.1002/aet2.10333. eCollection 2019 Jul.
- Background: PubMed 18955605Cho J, Kang GH, Kim EC, Oh YM, Choi HJ, Im TH, Yang JH, Cho YS, Chung HS. Comparison of manikin versus porcine models in cricothyrotomy procedure training. Emerg Med J. 2008 Nov;25(11):732-4. doi: 10.1136/emj.2008.059014.
- Background: PubMed 27621199Warren JN, Luctkar-Flude M, Godfrey C, Lukewich J. A systematic review of the effectiveness of simulation-based education on satisfaction and learning outcomes in nurse practitioner programs. Nurse Educ Today. 2016 Nov;46:99-108. doi: 10.1016/j.nedt.2016.08.023. Epub 2016 Aug 25.
- Background: PubMed 33415028Jabaay MJ, Marotta DA, Aita SL, Walker DB, Grcevich LO, Camba V, Nolin JR, Lyons J, Giannini J Jr. Medical Simulation-Based Learning Outcomes in Pre-Clinical Medical Education. Cureus. 2020 Dec 3;12(12):e11875. doi: 10.7759/cureus.11875.
- Background: PubMed 25802561Chan CH, Chan TN, Yuen MC, Tung WK. Evaluation of a simulation-based workshop on clinical performance for emergency physicians and nurses. World J Emerg Med. 2015;6(1):16-22. doi: 10.5847/wjem.j.1920-8642.2015.01.003.
- Background: PubMed 36858888Morton S, Avery P, Kua J, O'Meara M. Success rate of prehospital emergency front-of-neck access (FONA): a systematic review and meta-analysis. Br J Anaesth. 2023 May;130(5):636-644. doi: 10.1016/j.bja.2023.01.022. Epub 2023 Feb 28.
- Background: PubMed 36764288Zink N, Merelman A, Fisher AD, Lauria MJ. Emergency Reflex Action Drills and the Problem with Stress. J Spec Oper Med. 2023 Mar 15;23(1):54-58. doi: 10.55460/RCF2-CXS9.
- Background: PubMed 25572990Smith JE, Rickard A, Wise D. Traumatic cardiac arrest. J R Soc Med. 2015 Jan;108(1):11-6. doi: 10.1177/0141076814560837.
- Background: PubMed 17467567Burns KJ, Robinson K, Lowe EG. Evaluation of responses of an air medical helicopter program during a comprehensive emergency response drill. Air Med J. 2007 May-Jun;26(3):139-43. doi: 10.1016/j.amj.2006.08.009.
- National Protocol Dutch Emergency Medical ServicesLink provided by the sponsor.
- Link to information about Student Satisfaction and Self-confidence in Learning, Educational Practices Questionnaire and Simulation Design ScaleLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Iscander M Maissan principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Medical Services and Airway Management, run by Erasmus Medical Center at 1 site in Netherlands.
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 3 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 6 Apr 2026. 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 Netherlands. 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?
Self-confidence (time frame: Baseline, pre-training up to immediately after the training). 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 NCT06645288, which also lists 20 linked publications.
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 6 Apr 2026.