Tele-Support for Emergency Medical Technicians (POHCA)

Tele-Support for Emergency Medical Technicians Dealing With Pediatric Cardiac Arrest: a Randomized, Simulation-based Study

In this manikin-based simulation study the impact of tele-support during a simulated pediatric out-of-hospital cardiac arrest scenario on emergency medical technicians' guideline adherence, on gaze behavior as well as on performance of resuscitation management and cognitive load will be analyzed.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest
• Intervention / Treatment: Other: Tele-support

Detailed Description

80 emergency medical technicians (EMT) will take part in this simulation study. The participants will be confronted with a scenario of an 8-year old boy, while wearing eye tracking glasses. In a parallel group design, the teams will be randomly assigned to a group performing advanced life support (ALS) without further support (group 1) or with additional tele-support (group 2). In case of support, an emergency physician assists the team performing the cardiopulmonary resuscitation management via a real-time remote connection.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christina Hafner, MD, PhD; Phone Number: 004314040041020; Email: christina.hafner@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna
    • Contact: Christina Hafner, MD, PhD; Phone Number: 004314040041020; Email: christina.hafner@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18-65 years
• Active work as an emergency medical technician

Exclusion Criteria:

• Pregnancy
• Prior knowledge of study setting or simulation scenario

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No-Support; Participants randomized to Group 1 will perform the simulation scenario without tele-support.
Other: Tele-Support; Participants randomized to Group 2 will perform the simulation scenario with tele-support.	Other: Tele-support; via real-time audio-video connection through an experienced physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
guideline adherence	checklist (scale of 0-15 points)	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gaze behavior	dwell time in predefined areas of interest and fixation count	Day 1
teamwork performance	Team Emergency Assessment Measure (11 items on scale 0-4 for components leadership, team work and task management resulting in a total score with scale 0-44; scale 1-10 for overall global rating)	Day 1
cognitive load	NASA Taskload Index (scale of 0-20 points)	Day 1
Performance of cardiopulmonary resuscitation	Chest compressions (time to 1st compression, depth, frequency, total hands-off period); defibrillator: time to 1st rhythm analysis; ventilation: time to 1st ventilation, airway management; intravenous access: time to drug application; reversible causes: time to discussing potential reversible causes for cardiac arrest	Day 1
Technical feasibility	time of detection of visual attention through eye-tracking glasses	Day 1
Usability	Questionnaire (5-point Likert scale) on usability of tele-support and eye-tracking glasses	Day 1

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Ludwig Boltzmann Institute Digital Health and Patient Safety
• Investigators: Principal Investigator: Christina Hafner, MD, PhD, Medical University of Vienna

Publications and helpful links

General Publications

• Siebert JN, Lacroix L, Cantais A, Manzano S, Ehrler F. The Impact of a Tablet App on Adherence to American Heart Association Guidelines During Simulated Pediatric Cardiopulmonary Resuscitation: Randomized Controlled Trial. J Med Internet Res. 2020 May 27;22(5):e17792. doi: 10.2196/17792.
• Corazza F, Snijders D, Arpone M, Stritoni V, Martinolli F, Daverio M, Losi MG, Soldi L, Tesauri F, Da Dalt L, Bressan S. Development and Usability of a Novel Interactive Tablet App (PediAppRREST) to Support the Management of Pediatric Cardiac Arrest: Pilot High-Fidelity Simulation-Based Study. JMIR Mhealth Uhealth. 2020 Oct 1;8(10):e19070. doi: 10.2196/19070.
• Reis AG, Nadkarni V, Perondi MB, Grisi S, Berg RA. A prospective investigation into the epidemiology of in-hospital pediatric cardiopulmonary resuscitation using the international Utstein reporting style. Pediatrics. 2002 Feb;109(2):200-9. doi: 10.1542/peds.109.2.200.
• Drummond D, Arnaud C, Guedj R, Duguet A, de Suremain N, Petit A. Google Glass for Residents Dealing With Pediatric Cardiopulmonary Arrest: A Randomized, Controlled, Simulation-Based Study. Pediatr Crit Care Med. 2017 Feb;18(2):120-127. doi: 10.1097/PCC.0000000000000977.
• Gupta P, Tang X, Gall CM, Lauer C, Rice TB, Wetzel RC. Epidemiology and outcomes of in-hospital cardiac arrest in critically ill children across hospitals of varied center volume: a multi-center analysis. Resuscitation. 2014 Nov;85(11):1473-9. doi: 10.1016/j.resuscitation.2014.07.016. Epub 2014 Aug 7.
• Knudson JD, Neish SR, Cabrera AG, Lowry AW, Shamszad P, Morales DL, Graves DE, Williams EA, Rossano JW. Prevalence and outcomes of pediatric in-hospital cardiopulmonary resuscitation in the United States: an analysis of the Kids' Inpatient Database*. Crit Care Med. 2012 Nov;40(11):2940-4. doi: 10.1097/CCM.0b013e31825feb3f.
• Cheng A, Nadkarni VM, Mancini MB, Hunt EA, Sinz EH, Merchant RM, Donoghue A, Duff JP, Eppich W, Auerbach M, Bigham BL, Blewer AL, Chan PS, Bhanji F; American Heart Association Education Science Investigators; and on behalf of the American Heart Association Education Science and Programs Committee, Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; Council on Cardiovascular and Stroke Nursing; and Council on Quality of Care and Outcomes Research. Resuscitation Education Science: Educational Strategies to Improve Outcomes From Cardiac Arrest: A Scientific Statement From the American Heart Association. Circulation. 2018 Aug 7;138(6):e82-e122. doi: 10.1161/CIR.0000000000000583.
• Scheans P. Telemedicine for neonatal resuscitation. Neonatal Netw. 2014 Sep-Oct;33(5):283-7. doi: 10.1891/0730-0832.33.5.283.
• Agarwal AK, Gaieski DF, Perman SM, Leary M, Delfin G, Abella BS, Carr BG. Telemedicine REsuscitation and Arrest Trial (TREAT): A feasibility study of real-time provider-to-provider telemedicine for the care of critically ill patients. Heliyon. 2016 Apr 20;2(4):e00099. doi: 10.1016/j.heliyon.2016.e00099. eCollection 2016 Apr.
• Berrens ZJ, Gosdin CH, Brady PW, Tegtmeyer K. Efficacy and Safety of Pediatric Critical Care Physician Telemedicine Involvement in Rapid Response Team and Code Response in a Satellite Facility. Pediatr Crit Care Med. 2019 Feb;20(2):172-177. doi: 10.1097/PCC.0000000000001796.
• Siebert JN, Ehrler F, Combescure C, Lovis C, Haddad K, Hugon F, Luterbacher F, Lacroix L, Gervaix A, Manzano S; PedAMINES Trial Group. A mobile device application to reduce medication errors and time to drug delivery during simulated paediatric cardiopulmonary resuscitation: a multicentre, randomised, controlled, crossover trial. Lancet Child Adolesc Health. 2019 May;3(5):303-311. doi: 10.1016/S2352-4642(19)30003-3. Epub 2019 Feb 21.
• Corazza F, Arpone M, Tardini G, Stritoni V, Mormando G, Graziano A, Navalesi P, Fiorese E, Portalone S, De Luca M, Binotti M, Tortorolo L, Salvadei S, Nucci A, Monzani A, Genoni G, Bazo M, Cheng A, Frigo AC, Da Dalt L, Bressan S. Effectiveness of a Novel Tablet Application in Reducing Guideline Deviations During Pediatric Cardiac Arrest: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2327272. doi: 10.1001/jamanetworkopen.2023.27272.
• Corazza F, Stritoni V, Martinolli F, Daverio M, Binotti M, Genoni G, Ingrassia PL, De Luca M, Palmas G, Maccora I, Frigo AC, Da Dalt L, Bressan S. Adherence to guideline recommendations in the management of pediatric cardiac arrest: a multicentre observational simulation-based study. Eur J Emerg Med. 2022 Aug 1;29(4):271-278. doi: 10.1097/MEJ.0000000000000923. Epub 2022 Mar 29.
• Kruse CS, Krowski N, Rodriguez B, Tran L, Vela J, Brooks M. Telehealth and patient satisfaction: a systematic review and narrative analysis. BMJ Open. 2017 Aug 3;7(8):e016242. doi: 10.1136/bmjopen-2017-016242.
• Cooper S, Cant R, Porter J, Sellick K, Somers G, Kinsman L, Nestel D. Rating medical emergency teamwork performance: development of the Team Emergency Assessment Measure (TEAM). Resuscitation. 2010 Apr;81(4):446-52. doi: 10.1016/j.resuscitation.2009.11.027. Epub 2010 Feb 1.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Estimated): April 18, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: simulation; telemedicine; patient safety; emergency medicine; anaesthesiology; cognitive load; eye tracking; advanced life support; pediatric out-of-hospital cardiac arrest
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Emergencies; Heart Arrest
• Other Study ID Numbers: 1253/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No