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Cardiac ArrestPOHCANCT06362850

Tele-Support for Emergency Medical Technicians

A study testing Tele-support in people with Cardiac Arrest, run by Medical University of Vienna at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Cardiac Arrest
What is being tested?
Tele-support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteAustria
Study dates
8 Apr 2024to 11 Sep 2024
Phase
Interventional
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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Pregnancy
  • Prior knowledge of study setting or simulation scenario

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna

    Vienna, 1090

Other trials in Austria

About this study

Official title: 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.

Read the 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.

Conditions
Cardiac Arrest
Being tested
Tele-support
Keywords
simulation, pediatric out-of-hospital cardiac arrest, advanced life support, eye tracking, cognitive load, emergency medicine, patient safety, telemedicine, anaesthesiology
Medical subject headings
Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tele-supportOther

    via real-time audio-video connection through an experienced physician

Study groups in NCT06362850
Study groupRoleWhat they receive
No-SupportNo interventionParticipants randomized to Group 1 will perform the simulation scenario without tele-support.
Tele-SupportOtherParticipants randomized to Group 2 will perform the simulation scenario with tele-support.
Receives: Other: Tele-support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. guideline adherence

    checklist (scale of 0-15 points)

    Measured: Day 1

Secondary outcomes (6)

  1. gaze behavior

    dwell time in predefined areas of interest and fixation count

    Measured: Day 1

  2. 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)

    Measured: Day 1

  3. cognitive load

    NASA Taskload Index (scale of 0-20 points)

    Measured: Day 1

  4. 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

    Measured: Day 1

  5. Technical feasibility

    time of detection of visual attention through eye-tracking glasses

    Measured: Day 1

  6. Usability

    Questionnaire (5-point Likert scale) on usability of tele-support and eye-tracking glasses

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2024
  2. Study start8 Apr 2024
  3. Primary completion11 Sep 2024
  4. Study completion11 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
In a manikin-based simulation study, the participants will be randomized to either performing the scenario with tele-support or without tele-support (80 participants 40 groups, 20 groups with tele-support, 20 groups without tele-support).
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06362850
Sponsor's protocol ID
1253/2023
Acronym
POHCA
Status last verified
Apr 2024
First submitted
3 Apr 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available to other researchers.

Publications

  • 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.

    PubMed 28165347

  • 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.

    PubMed 11826196

  • 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.

    PubMed 25110249

  • 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.

    PubMed 22932398

  • 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.

    PubMed 29930020

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

    PubMed 25161137

  • 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.

    PubMed 27441272

  • 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.

    PubMed 30395026

  • 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.

    PubMed 30797722

  • 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.

    PubMed 32292179

  • 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.

    PubMed 37535352

  • 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.

    PubMed 35404331

  • 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.

    PubMed 32788142

  • 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.

    PubMed 28775188

  • 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.

    PubMed 20117874

Questions about this trial

What is this clinical trial studying?

A study testing Tele-support in people with Cardiac Arrest, run by Medical University of Vienna at 1 site in Austria.

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 2 inclusion and 2 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 19 Sep 2024. 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 Austria. 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?

guideline adherence (time frame: Day 1). 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 NCT06362850, which also lists 15 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 19 Sep 2024.

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