NCT06645288

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Sep 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress81%
Sep 2024Sep 2026

Study Start

First participant enrolled

September 9, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 11, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

2.1 years

First QC Date

October 11, 2024

Last Update Submit

October 14, 2024

Conditions

Keywords

Emergency Reflex Action DrillEmergency Surgical AirwayEmergency Medical ServicesPrehospitalCricothyrotomyConiotomyPorcine model3D modelSelf-confidence

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline, pre-training up to immediately after the training

Secondary Outcomes (2)

  • Training model

    Immediately after the training

  • Self-confidence real life cases

    Through study completion, an average of 1 year

Interventions

Emergency Reflex Action Drill in performing Emergency Surgical Airway

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Registered Dutch paramedic
  • Ambulance driver on Advanced Life Support Ambulance
  • Participant in the two-day trauma course.

You may not qualify if:

  • Medium care ambulance paramedic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academie van Ambulancezorg

Harderwijk, Gelderland, 3847 LG, Netherlands

RECRUITING

Related Publications (20)

  • 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.

    PMID: 28084900BACKGROUND
  • Armstrong 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.

    PMID: 32444066BACKGROUND
  • Iverson 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.

    PMID: 25975338BACKGROUND
  • Gustafson 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.

    PMID: 31360821BACKGROUND
  • Cho 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.

    PMID: 18955605BACKGROUND
  • Warren 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.

    PMID: 27621199BACKGROUND
  • Jabaay 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.

    PMID: 33415028BACKGROUND
  • Chan 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.

    PMID: 25802561BACKGROUND
  • Morton 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.

    PMID: 36858888BACKGROUND
  • Zink 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.

    PMID: 36764288BACKGROUND
  • Smith JE, Rickard A, Wise D. Traumatic cardiac arrest. J R Soc Med. 2015 Jan;108(1):11-6. doi: 10.1177/0141076814560837.

    PMID: 25572990BACKGROUND
  • Burns 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.

    PMID: 17467567BACKGROUND
  • Anderson 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.

    PMID: 29305380BACKGROUND
  • Chrimes 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.

    PMID: 27440673BACKGROUND
  • Reardon 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.

    PMID: 35001821BACKGROUND
  • Wang HE, Mann NC, Mears G, Jacobson K, Yealy DM. Out-of-hospital airway management in the United States. Resuscitation. 2011 Apr;82(4):378-85. doi: 10.1016/j.resuscitation.2010.12.014. Epub 2011 Feb 1.

    PMID: 21288624BACKGROUND
  • Schauer SG, Naylor JF, Maddry JK, Beaumont DM, Cunningham CW, Blackburn MB, April MD. Prehospital Airway Management in Iraq and Afghanistan: A Descriptive Analysis. South Med J. 2018 Dec;111(12):707-713. doi: 10.14423/SMJ.0000000000000906.

    PMID: 30512120BACKGROUND
  • Mabry RL, Frankfurt A. An analysis of battlefield cricothyrotomy in Iraq and Afghanistan. J Spec Oper Med. 2012 Spring;12(1):17-23. doi: 10.55460/FYQG-8E49.

    PMID: 22427045BACKGROUND
  • Mabry RL, Edens JW, Pearse L, Kelly JF, Harke H. Fatal airway injuries during Operation Enduring Freedom and Operation Iraqi Freedom. Prehosp Emerg Care. 2010 Apr-Jun;14(2):272-7. doi: 10.3109/10903120903537205.

    PMID: 20199236BACKGROUND
  • Brown CA 3rd, Cox K, Hurwitz S, Walls RM. 4,871 Emergency airway encounters by air medical providers: a report of the air transport emergency airway management (NEAR VI: "A-TEAM") project. West J Emerg Med. 2014 Mar;15(2):188-93. doi: 10.5811/westjem.2013.11.18549.

    PMID: 24672610BACKGROUND

Related Links

Study Officials

  • Iscander M Maissan

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Iscander M Maissan

CONTACT

Denyse D Paalvast

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. I.M. Maissan MD PhD

Study Record Dates

First Submitted

October 11, 2024

First Posted

October 16, 2024

Study Start

September 9, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

October 16, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Beginning after 6 months after publication, ending 10 years after publication
Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Locations