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Ventricular Fibrillation Following Out-of-hospital Cardiac Arrest

19 de abril de 2022 actualizado por: University Hospital Southampton NHS Foundation Trust

An Estimation of the Incidence of Ventricular Fibrillation (VF) at the Initial Time of Collapse in Out-of-Hospital Cardiac Arrest and the Duration of VF Prior to Its Deterioration to a Non-Shockable Rhythm

The majority of survivors suffering an out-of-hospital cardiac arrest (OHCA) are those who initially present with a shockable rhythm, which is usually ventricular fibrillation (VF). When untreated, VF progresses to asystole over a short period of time so the percentage of those with a survivable rhythm also decreases with time.

There is relatively little data exploring the initial rate of VF and the time course of its subsequent progression to a non-shockable rhythm. An understanding of this data will give a better picture of how potentially survivable rhythms (VF) change with time and guide the response times that are required to ensure arrival before VF deteriorates to asystole.

The Investigators will use the UK OHCA outcomes database to examine the percentage of patients presenting with VF as the initial rhythm according to time since collapse in order to establish the rate at which VF deteriorates to asystole.

Descripción general del estudio

Descripción detallada

Patients suffering an out-of-hospital cardiac arrest (OHCA) present in one of two broad groups; non-shockable or shockable rhythms. The former group comprises asystole or pulseless electrical activity (PEA) and the latter, ventricular fibrillation (VF) or ventricular tachycardia (VT). Recent UK data show that the majority present in a non-shockable rhythm (asystole 50.9%, PEA 22.8%) with only 23% in a shockable rhythm, primarily ventricular fibrillation. (VT represents only a small proportion of shockable rhythms).

Whilst survival from any of these rhythms is poor, the majority of survivors are those who initially present with a shockable rhythm. In a recent pooled analysis of the PARAMEDIC2 and PACA trials, 32.8% of those in shockable rhythms achieved ROSC, compared with 46.0% in shockable rhythms. Of those achieving neurologically intact survival only 0.55% of those in non-shockable rhythms did so, compared with 8.63% in shockable rhythms; a 16-fold difference in survival. Therefore the vast majority of those who survive do so because they present in VF, which is potentially a survivable rhythm.

The initial VF is a relatively short-term arrhythmia. As cellular energy reserves become depleted during the cardiac arrest, the myocyte electrical activity declines resulting in low amplitude VF and eventually a cessation, at which time the rhythm changes to asystole. The proportion of patients presenting in ventricular fibrillation decreases with time and therefore the size of the cohort of patients with a potentially survivable rhythm also decreases with time. Clearly the quicker the rescuer response, the more likely the patient is to still be in VF and the more likely this rhythm can be treated successfully. For every minute without CPR, survival from witnessed ventricular fibrillation (VF) cardiac arrest decreases by 7-10%. Once VF deteriorates to asystole, then survival is unlikely.

Most studies documenting the incidence of VF as the presenting rhythm at OHCA report a cumulative value based on the average of the study's EMS response times. There is relatively little data exploring the initial rate of VF and the time course of its subsequent progression to a non-shockable rhythm. Although earlier studies of OHCA reported high rates of initial VF such as a study from Sweden in 2000, which documented an initial rate of 43%, these high initial rates of VF are consistently not reported in current studies, where the incidence is typically 20-25%, despite improvements in the delivery of bystander CPR which can prolong the VF duration. Although there is contemporary data documenting the overall rates of initial VF at OHCA, no current UK study has examined how the incidence of initial VF changes with time from onset of cardiac arrest (as measured from time from collapse).

An understanding of this data will give a better picture of how potentially survivable rhythms (VF) change with time and guide the response times that are required to ensure arrival before VF deteriorates to asystole.

Additionally, an extrapolation of data into the time window prior to ambulance arrival may allow an estimate of the percentage of patients where VF is the initial rhythm at the time of cardiac arrest onset. Although one study has estimated this as 60-70%, and another as high as 80-90%, these estimates are based on data that does not reflect current estimates of VF incidence. There is also little contemporary data on the rate at which VF progresses to asystole when untreated. Again, historic studies have estimated the rate of VF dissolution into asystole of approximately 2% per minute, but this is not consistent with the current relatively low rates of initial VF, the rapid decline in survival with time, even for VF and possible confounding effect of bystander CPR which is not factored in to most studies.

The Investigators will use five years of data from the UK Warwick University OHCA outcomes database to examine the percentage of patients presenting with VF as the initial rhythm according to time since collapse in order to establish the rate at which VF deteriorates to asystole.

Tipo de estudio

De observación

Inscripción (Anticipado)

15000

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Charles Deakin, MD
  • Número de teléfono: 4070 02380777222
  • Correo electrónico: charles.deakin@nhs.net

Ubicaciones de estudio

    • Hampshire
      • Southampton, Hampshire, Reino Unido, SO16 6YD
        • University Hospital Southampton

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

All patients in cardiac arrest attended by ambulance services (England) where data has been submitted to the Warwick University OHCA outcomes database.

Descripción

Inclusion Criteria:

  • Adult
  • Out-of-hospital cardiac arrest
  • Known time of collapse
  • Known initial rhythm documented by ambulance crew

Exclusion Criteria:

  • Paediatric cases
  • Trauma

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
OHCA attended by ambulance service
All adults attended by ambulance service where time of collapse and initial rhythm is known.
There are no interventions - this is a database study only

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Presenting rhythm
Periodo de tiempo: From 01.01.2016 to 31.12.2020
An estimate of the incidence of VF at the initial time of collapse from a out-of-hospital cardiac arrest.
From 01.01.2016 to 31.12.2020

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

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Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Anticipado)

1 de septiembre de 2022

Finalización primaria (Anticipado)

1 de enero de 2023

Finalización del estudio (Anticipado)

1 de mayo de 2023

Fechas de registro del estudio

Enviado por primera vez

5 de abril de 2022

Primero enviado que cumplió con los criterios de control de calidad

5 de abril de 2022

Publicado por primera vez (Actual)

13 de abril de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de abril de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

19 de abril de 2022

Última verificación

1 de abril de 2022

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Any request for IPD must directed to the Warwick OHCA outcomes database administrator.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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