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Simulation TrainingNCT04338490

Effect of the Use of a Visual Feedback Device in RCP Trainings

A study testing Feedback mannequim in people with Simulation Training, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.

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

To verify the efficacy of manikins with feedback in the training of physicians and nurses in the courses of Advanced Cardiac Life Support (ACLS) authorized by the American Heart Association (AHA) when compared to the traditional training form. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Simulation Training
What is being tested?
Feedback mannequim
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
209 participants
Where
1 siteBrazil
Study dates
1 May 2019to 10 Nov 2019
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 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Instituto de Cardiologia do Rio Grande do Sul - Fundação Universitária de Cardiologia

    Porto Alegre, Rio Grande do Sul, 90040-370

Other trials in Brazil

About this study

Official title: Effect of a Visual Feedback Device in Cardiopulmonary Resuscitation Training in AHA Certified ACLS Courses: Randomized Clinical Trial

To verify the efficacy of manikins with feedback in the training of physicians and nurses in the courses of Advanced Cardiac Life Support (ACLS) authorized by the American Heart Association (AHA) when compared to the traditional training form.

Read the detailed description

Introduction: The Cardiopulmonary Arrest (CRP) is the largest medical emergency, training is fundamental for a good performance in Cardiopulmonary Resuscitation (CPR). In a realistic simulation scenario, the results tend to improve with the use of feedback manikins that evaluate the quality parameters in CPR and show in real time what the rescuer needs to improve in order to be successful in training and increase the probability of success in future real care. Objective: To verify the efficacy of the manikins with feedback in the training of physicians and nurses in the courses of Advanced Cardiac Life Support (ACLS) authorized by the American Heart Association (AHA). Methods: Comparison of CPR performance of ACLS students. The intervention group will be submitted to the real-time feedback of the manikins, the control group will receive feedback from the instructor. Statistical analysis will consist of inter-group comparisons and will cover mean, standard deviation, and parametric tests such as Student's T test. The results will be related to the characteristics of the sample, including anthropometric profile, profession, training time, practice area, previous training with a focus on CPR and physical exercise practice.

Being tested
Feedback mannequim
Keywords
cardiopulmonary ressuscitattion, education medical continuing, emergency medical services, simulation training, feedback dummy

What participants receive

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

  • Feedback mannequimDevice

    The intervention group received rcp training with their performance being evaluated in real time so that they could correct themselves

Study groups in NCT04338490
Study groupRoleWhat they receive
InterventionExperimentalNot described
Receives: Device: Feedback mannequim
ControlNo interventionNot described

What is being measured

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

  1. The feedback mannequim is as effective as an AHA instructor

    Measured: 6 months

Timeline

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

  1. First posted8 Apr 2020
  2. Study start1 May 2019
  3. Primary completion1 Jul 2019
  4. Study completion10 Nov 2019

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
Masking
None (open label)
Enrolment
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04338490
Sponsor's protocol ID
5637/19
Status last verified
Sep 2020
First submitted
16 Jan 2020
Last updated
22 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nolan JP, Soar J, Smith GB, Gwinnutt C, Parrott F, Power S, Harrison DA, Nixon E, Rowan K; National Cardiac Arrest Audit. Incidence and outcome of in-hospital cardiac arrest in the United Kingdom National Cardiac Arrest Audit. Resuscitation. 2014 Aug;85(8):987-92. doi: 10.1016/j.resuscitation.2014.04.002. Epub 2014 Apr 15.

    PubMed 24746785

  • Austin AL, Spalding CN, Landa KN, Myer BR, Cure D, Smith JE, Platt G, King HC. A Randomized Control Trial of Cardiopulmonary Feedback Devices and Their Impact on Infant Chest Compression Quality: A Simulation Study. Pediatr Emerg Care. 2020 Feb;36(2):e79-e84. doi: 10.1097/PEC.0000000000001312.

    PubMed 29084067

  • Link MS, Berkow LC, Kudenchuk PJ, Halperin HR, Hess EP, Moitra VK, Neumar RW, O'Neil BJ, Paxton JH, Silvers SM, White RD, Yannopoulos D, Donnino MW. Part 7: Adult Advanced Cardiovascular Life Support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S444-64. doi: 10.1161/CIR.0000000000000261. No abstract available.

    PubMed 26472995

  • Choi B, Asselin N, Pettit CC, Dannecker M, Machan JT, Merck DL, Merck LH, Suner S, Williams KA, Jay GD, Kobayashi L. Simulation-based Randomized Comparative Assessment of Out-of-Hospital Cardiac Arrest Resuscitation Bundle Completion by Emergency Medical Service Teams Using Standard Life Support or an Experimental Automation-assisted Approach. Simul Healthc. 2016 Dec;11(6):365-375. doi: 10.1097/SIH.0000000000000178.

    PubMed 27509064

  • Iskrzycki L, Smereka J, Rodriguez-Nunez A, Barcala Furelos R, Abelarias Gomez C, Kaminska H, Wieczorek W, Szarpak L, Nadolny K, Galazkowski R, Ruetzler K, Ladny JR. The impact of the use of a CPRMeter monitor on quality of chest compressions: a prospective randomised trial, cross-simulation. Kardiol Pol. 2018;76(3):574-579. doi: 10.5603/KP.a2017.0255. Epub 2018 Jan 3.

    PubMed 29297195

  • Kirkbright S, Finn J, Tohira H, Bremner A, Jacobs I, Celenza A. Audiovisual feedback device use by health care professionals during CPR: a systematic review and meta-analysis of randomised and non-randomised trials. Resuscitation. 2014 Apr;85(4):460-71. doi: 10.1016/j.resuscitation.2013.12.012. Epub 2013 Dec 21.

    PubMed 24361457

Questions about this trial

What is this clinical trial studying?

A study testing Feedback mannequim in people with Simulation Training, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.

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 0 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 22 Sep 2020. 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 Brazil. 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?

The feedback mannequim is as effective as an AHA instructor (time frame: 6 months). 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 NCT04338490, which also lists 6 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 22 Sep 2020.

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