Tele-Support for Emergency Medical Technicians

Cardiac Arrest Clinical Trial

— POHCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06362850
• Other study ID #: 1253/2023
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2024
• Source: Medical University of Vienna
• Contact: Christina Hafner, MD, PhD
• Phone: 004314040041020
• Email: christina.hafner[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 1, 2024
• Est. primary completion date: April 18, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy
• Prior knowledge of study setting or simulation scenario

Related Conditions & MeSH terms

• Cardiac Arrest
• Emergencies
• Heart Arrest

Intervention

Other:
• Tele-support
via real-time audio-video connection through an experienced physician

Locations

Country	Name	City	State
Austria	Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Ludwig Boltzmann Institute Digital Health and Patient Safety

Country where clinical trial is conducted

Austria, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Scheans P. Telemedicine for neonatal resuscitation. Neonatal Netw. 2014 Sep-Oct;33(5):283-7. doi: 10.1891/0730-0832.33.5.283. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	guideline adherence	checklist (scale of 0-15 points)	Day 1
Secondary	gaze behavior	dwell time in predefined areas of interest and fixation count	Day 1
Secondary	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
Secondary	cognitive load	NASA Taskload Index (scale of 0-20 points)	Day 1
Secondary	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
Secondary	Technical feasibility	time of detection of visual attention through eye-tracking glasses	Day 1
Secondary	Usability	Questionnaire (5-point Likert scale) on usability of tele-support and eye-tracking glasses	Day 1