Effect of the Use of a Visual Feedback Device in RCP Trai... | NCT04338490

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

NCT04338490

Sponsor

Instituto de Cardiologia do Rio Grande do Sul

Status

Completed

Last Update Posted

Sep 22, 2020Actual

Enrollment

209Actual

Phase

Not Applicable

Conditions

Simulation Training

Interventions

Feedback mannequim

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

Jul 1, 2019Actual

Completion Date

Nov 10, 2019Actual

First Submitted Date

Jan 16, 2020

First Submission Date that Met QC Criteria

Apr 6, 2020

First Posted Date

Apr 8, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2020

Last Update Posted Date

Sep 22, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carina Trindade de Castro, Principal researcher, Instituto de Cardiologia do Rio Grande do SulPrincipal Investigator

Lead Sponsor

Instituto de Cardiologia do Rio Grande do SulOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

209Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental		Device: Feedback mannequim
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Feedback mannequim	Device	The intervention group received rcp training with their performance being evaluated in real time so that they could correct themselves	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The feedback mannequim is as effective as an AHA instructor		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Be an ACLS student and sign the TCLE. -

Exclusion Criteria: Refusing to sign the TCLE

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Juarez Dr Neuhaus Barbisan	Instituto de Cardiologia do Rio Grande do Sul	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto de Cardiologia do Rio Grande do Sul - Fundação Universitária de Cardiologia		Porto Alegre	Rio Grande do Sul	90040-370	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24746785	Background	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.
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