NCT07623447

Brief Summary

Introduction: Cardiopulmonary arrest is one of the most prevalent cardiovascular emergencies worldwide, associated with high morbidity and mortality. In Brazil, approximately 14 million people have some form of cardiovascular disease, accounting for around 400,000 deaths per year, which corresponds to 30% of all deaths recorded in the country. Cardiovascular diseases were responsible for more than 198,000 deaths among Brazilians in 2020 and represent the main underlying causes of cardiac arrest. Therefore, early recognition of cardiac arrest can lead to improved outcomes and better patient prognosis. Given this scenario, the need to train healthcare professionals in the appropriate management of cardiac arrest-as well as to educate the general population-is evident. In this context, Resolution No. 704/2022 of the Federal Council of Nursing (COFEN) regulates and authorizes nurses to manage cardiac arrest and perform electrical therapy, including defibrillation, in the absence of a physician, provided they are properly trained. This study proposes a randomized clinical trial to evaluate the impact of training nurses through realistic simulation for the management of cardiac arrest with a shockable rhythm. Objective: To evaluate the impact of training nurses using realistic simulation to perform cardiopulmonary resuscitation (CPR), with an emphasis on electrical therapy. Methods: This is a randomized clinical trial. Expected Results: This study is expected to expand and enhance nurses' knowledge and skills, enabling them to perform defibrillation in cases of cardiac arrest due to shockable rhythms in their work environments, thereby promoting higher quality care and improving patient outcomes.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

July 17, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

March 18, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2027

Last Updated

June 3, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

July 17, 2025

Last Update Submit

June 1, 2026

Conditions

Keywords

cardiorespiratory arrestNursing trainingSimulationdefibrillation

Outcome Measures

Primary Outcomes (1)

  • Primary outcome

    Description: Measure the impact of realistic simulation-mediated training for nurses facing a CPA situation with a shockable rhythm.

    Four hours

Study Arms (2)

Theoretical-Practical Training

EXPERIMENTAL

Theoretical-Practical Training: The intervention group will participate in a one-hour theoretical-practical session based on realistic simulation. The training will cover the following topics: electrocardiography; recognition of cardiac arrest rhythms, including pulseless ventricular tachycardia (pVT), ventricular fibrillation (VF), asystole, and pulseless electrical activity (PEA); identification of shockable and non-shockable rhythms; operation and key functionalities of the defibrillator; and advanced life support, with an emphasis on cardiac arrest management.

Behavioral: CPR training for nurses with the use of electrical therapy

Control group: the group will receive an explanatory leaflet with the algorithm for cardiorespirator

PLACEBO COMPARATOR

This group of nurses will receive an explanatory leaflet outlining the role of nurses in cardiopulmonary arrest (CPA), including the use of electrical therapy, specifically defibrillation. The leaflet will also include the algorithm describing the sequence of actions for cardiopulmonary resuscitation (CPR).

Behavioral: CPR training for nurses with the use of electrical therapy

Interventions

Theoretical-Practical Training: the Intervention group will receive a theoretical-practical class using realistic simulation addressing the following topics: electrocardiography; knowledge of cardiorespiratory arrest rhythms: pulseless ventricular tachycardia, ventricular fibrillation, asystole, pulseless electrical activity; identification of shockable and non-shockable rhythms; use of the defibrillator and its functionalities; and advanced life support with an emphasis on cardiorespiratory arrest management. The activity will last one hour.

Control group: the group will receive an explanatory leaflet with the algorithm for cardiorespiratorTheoretical-Practical Training

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Nurses with more than one year of professional experience,

You may not qualify if:

  • Nurses who are instructors of ACLS, PALS, or BLS, Nurses who have already participated in any of these trainings.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Cardiologia do RS

Porto Alegre, Rio Grande do Sul, 90040371, Brazil

Location

Related Links

MeSH Terms

Conditions

Heart Arrest

Interventions

Nurses

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The Randomized Clinical Trial will include nurses with more than one year of experience who agree to participate in the study by signing the Informed Consent Form (Appendix 2). Professionals will be invited by email or WhatsApp message, sent directly to the professional and to the healthcare institutions, and also by invitation sent by the Regional Nursing Council (COREN/RS). To preserve the anonymity of participants in the evaluation test, each will be assigned a number, preceded by the letter "E," as a codename. Participants will be randomized using an electronic randomization system (random.org) and divided into two groups: Control Group (n=30) and Intervention Group (n=30). Professionals who agree to participate in the study will be blinded to the intended intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2025

First Posted

June 3, 2026

Study Start

March 18, 2026

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

March 20, 2027

Last Updated

June 3, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations