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Cardiac Arrest, Out-Of-HospitalNCT05325385

Ventricular Fibrillation Following Out-of-hospital Cardiac Arrest

An observational study of Cardiac Arrest, Out-Of-Hospital and Ventricular Fibrillation, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
How many people
15,000 participants
Where
1 siteUnited Kingdom
Study dates
Sep 2022to May 2023
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Paediatric cases
  • Trauma

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • University Hospital Southampton

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

About this study

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

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.

Read the detailed description

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.

Being tested
There are no interventions - this is a database study only
Keywords
Cardiac arrest, Ventricular fibrillation, Ambulance, Survival
Medical subject headings
Out-of-Hospital Cardiac Arrest, Ventricular Fibrillation, Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • There are no interventions - this is a database study onlyOther

    There are no interventions - this is a database study only

Study groups in NCT05325385
Study groupRoleWhat they receive
OHCA attended by ambulance serviceAll adults attended by ambulance service where time of collapse and initial rhythm is known.
Receives: Other: There are no interventions - this is a database study only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presenting rhythm

    An estimate of the incidence of VF at the initial time of collapse from a out-of-hospital cardiac arrest.

    Measured: From 01.01.2016 to 31.12.2020

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2022
  2. Study startSep 2022 (estimated)
  3. Primary completionJan 2023 (estimated)
  4. Study completionMay 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Other
Enrolment
15,000 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT05325385
Sponsor's protocol ID
IRAS Project ID: 315145
Status last verified
Apr 2022
First submitted
5 Apr 2022
Last updated
27 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Any request for IPD must directed to the Warwick OHCA outcomes database administrator.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Arrest, Out-Of-Hospital and Ventricular Fibrillation, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Charles Deakin, MD (02380777222 ext. 4070, charles.deakin@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presenting rhythm (time frame: From 01.01.2016 to 31.12.2020). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.

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