- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07623447
Impact of Realistic Simulation Training on Nurses' Cardiopulmonary Resuscitation Performance (SIM-CPR Nurses)
Impact of Training Nurses Through Realistic Simulation for Performing Cardiopulmonary Resuscitation With Emphasis on Electrical Therapy: Randomized Clinical Trial
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazílie, 90040371
- Instituto de Cardiologia do RS
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Theoretical-Practical Training
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.
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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.
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Komparátor placeba: Control group: the group will receive an explanatory leaflet with the algorithm for cardiorespirator
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).
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Primary outcome
Časové okno: Four hours
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Description: Measure the impact of realistic simulation-mediated training for nurses facing a CPA situation with a shockable rhythm.
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Four hours
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Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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Klinické studie na Kardiorespirační zástava
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