- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04338490
Effect of the Use of a Visual Feedback Device in RCP Trainings
September 20, 2020 updated by: Carina Trindade de Castro, Instituto de Cardiologia do Rio Grande do Sul
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
209
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil, 90040-370
- Instituto de Cardiologia do Rio Grande do Sul - Fundação Universitária de Cardiologia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria: Be an ACLS student and sign the TCLE. -
Exclusion Criteria: Refusing to sign the TCLE
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
|
The intervention group received rcp training with their performance being evaluated in real time so that they could correct themselves
|
|
No Intervention: Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The feedback mannequim is as effective as an AHA instructor
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Juarez Dr Neuhaus Barbisan, Instituto de Cardiologia do Rio Grande do Sul
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Circulation. 2015 Dec 15;132(24):e385.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2019
Primary Completion (Actual)
July 1, 2019
Study Completion (Actual)
November 10, 2019
Study Registration Dates
First Submitted
January 16, 2020
First Submitted That Met QC Criteria
April 6, 2020
First Posted (Actual)
April 8, 2020
Study Record Updates
Last Update Posted (Actual)
September 22, 2020
Last Update Submitted That Met QC Criteria
September 20, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 5637/19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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