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Ventricular Fibrillation Following Out-of-hospital Cardiac Arrest

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05325385
Recruitment Status : Not yet recruiting
First Posted : April 13, 2022
Last Update Posted : April 27, 2022
Sponsor:
Collaborator:
Warwick University Clinical Trials Unit
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

Brief Summary:

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.


Condition or disease Intervention/treatment
Cardiac Arrest, Out-Of-Hospital Ventricular Fibrillation Other: There are no interventions - this is a database study only

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 15000 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 1 Day
Official Title: 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
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
OHCA attended by ambulance service
All adults attended by ambulance service where time of collapse and initial rhythm is known.
Other: There are no interventions - this is a database study only
There are no interventions - this is a database study only




Primary Outcome Measures :
  1. Presenting rhythm [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients in cardiac arrest attended by ambulance services (England) where data has been submitted to the Warwick University OHCA outcomes database.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Paediatric cases
  • Trauma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05325385


Contacts
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Contact: Charles Deakin, MD 02380777222 ext 4070 charles.deakin@nhs.net

Locations
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United Kingdom
University Hospital Southampton
Southampton, Hampshire, United Kingdom, SO16 6YD
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
Warwick University Clinical Trials Unit
Additional Information:
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Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT05325385    
Other Study ID Numbers: IRAS Project ID: 315145
First Posted: April 13, 2022    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Any request for IPD must directed to the Warwick OHCA outcomes database administrator.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Southampton NHS Foundation Trust:
Cardiac arrest
Ventricular fibrillation
Ambulance
Survival
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Ventricular Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes