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Active, Not Recruiting

NCT Number: NCT07623447

Impact of Realistic Simulation Training on Nurses' Cardiopulmonary Resuscitation Performance

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Cardiologia do RS

Porto Alegre, Rio Grande do Sul, 90040371, Brazil

About this study

Cardiopulmonary arrest (CPA) represents one of the most prevalent cardiovascular emergencies worldwide and is associated with high morbidity and mortality. In Brazil, approximately 14 million individuals have some form of cardiovascular disease (CVD), accounting for nearly 400,000 deaths annually, which corresponds to about 30% of all deaths recorded in the country.

According to the Brazilian Society of Cardiology, CVDs were responsible for more than 198,000 deaths in 2020 and constitute the primary underlying causes of CPA. Early recognition of CPA is therefore critical, as it is directly associated with improved outcomes and better patient prognosis.

CPA may present with four cardiac rhythms: asystole, pulseless electrical activity (PEA), ventricular fibrillation (VF), and pulseless ventricular tachycardia (pVT). Among these, only VF and pVT are shockable rhythms. In adult patients with sudden cardiac arrest due to VF or pVT, the heart exhibits disorganized electrical activity that is ineffective in maintaining perfusion to vital organs. In such cases, survival rates are significantly higher when immediate chest compressions and early defibrillation are performed.

Defibrillation is defined as the delivery of a controlled electrical shock aimed at terminating an abnormal cardiac rhythm, particularly life-threatening arrhythmias. During defibrillation, an electrical current induces simultaneous depolarization of myocardial cells. Although this intervention does not directly restore effective cardiac output, it creates the conditions necessary for the resumption of organized electrical activity. If myocardial viability is preserved, pacemaker cells may regain control of cardiac rhythm, resulting in the return of spontaneous circulation (ROSC).

The energy dose delivered during defibrillation depends on the type of defibrillator used. Biphasic defibrillators, currently the most widely used devices, typically deliver initial shocks ranging from 120 to 200 joules, with the possibility of escalation according to manufacturer recommendations. In contrast, monophasic defibrillators generally require a fixed dose of 360 joules. A monophasic waveform delivers current in a single direction, whereas a biphasic waveform alternates the direction of current flow, a phenomenon known as polarity reversal, which improves defibrillation efficiency.

Evidence consistently demonstrates that early defibrillation is a key determinant of survival in cardiac arrest. The probability of successful defibrillation decreases rapidly over time, with each minute of untreated cardiac arrest resulting in a 7-10% reduction in the likelihood of ROSC. When cardiopulmonary resuscitation (CPR) is initiated promptly, this decline becomes more gradual, averaging 3-4% per minute. Early CPR can double or even triple survival rates in cases of witnessed sudden cardiac arrest. Furthermore, VF tends to deteriorate into asystole within minutes, reinforcing that immediate defibrillation is the definitive treatment for shockable rhythms.

Large-scale studies have demonstrated a strong association between shorter time to defibrillation and improved survival to hospital discharge. In one study involving over 12,000 participants, 4,546 presented with VF. A reduced interval between rhythm recognition and defibrillation was significantly associated with increased survival rates. When defibrillation was performed immediately after rhythm identification, return of spontaneous circulation occurred in nearly all cases. However, after 60 seconds, success rates declined to approximately 80-90%. Survival was 74% among patients who received defibrillation within the first three minutes after collapse, compared to only 49% among those who received defibrillation after this period.

Although undergraduate curricula in healthcare fields, particularly medicine and nursing, include training in cardiac arrest management, this type of care remains a significant challenge for many professionals. This highlights the need for more effective educational strategies aimed at improving knowledge retention, technical skills, and clinical performance in emergency situations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Nurses with more than one year of professional experience,

Exclusion criteria

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

Treatment and study plan

CPR training for nurses with the use of electrical therapy

Behavioral

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.

Primary outcomes

  1. Primary outcome

    Time frame: Four hours

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

Sponsors and collaborators

Lead sponsor

Instituto de Cardiologia do Rio Grande do Sul

Other

Registry information

Official study title

Impact of Training Nurses Through Realistic Simulation for Performing Cardiopulmonary Resuscitation With Emphasis on Electrical Therapy: Randomized Clinical Trial

Acronym: SIM-CPR Nurses

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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