Cardiac ArrestNCT04604639
Do Patients Suffering a Cardiac Arrest Present to the Ambulance Service With Symptoms in the Preceeding 48hrs?
An observational study of Cardiac Arrest, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
A cardiac arrest is often preceeded by a varying period of physiological deterioration which if acted upon may prevent the cardiac arrest. We aim to review patients presenting to the ambulance service with cardiac arrest so see if they had contacted the ambulance service in the preceeding 48 hrs to understand if… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- NEWS2 score
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2018to 20 Feb 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients calling for an emergency ambulance in the South Central Ambulance Service region, where an emergency ambulnace was dispatched and a patient intervention occurred.
Who may be able to join
- All patients seen by SCAS ambulance crews and suffering a cardiac arrest within the following 48 hrs
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South Central Ambulance Service
Otterbourne, Hampshire, SO21 2RU
About this study
Official title: Do Patients Suffering an Out-of-hospital Cardiac Arrest Present to the Ambulance Service With Symptoms in the Preceeding 48hrs?
A cardiac arrest is often preceeded by a varying period of physiological deterioration which if acted upon may prevent the cardiac arrest. We aim to review patients presenting to the ambulance service with cardiac arrest so see if they had contacted the ambulance service in the preceeding 48 hrs to understand if warning symptoms were missed or not acted upon appropriately.
Read the detailed description
The UK ambulance services are called to attend 60,000 out-of-hospital cardiac arrests (OHCA) each year. Hospital studies have shown that many patients who suffer an in-hospital cardiac arrest (IHCA) have been deteriorating for the preceeding 48 hrs and suggest that many IHCA are potentially avoidable if this deterioration is identified and actued on promptly. No similar study has been performed to see if patients suffering OHCA have also presented with warning signs in the preceeding 48 hrs that were overlooked.
- Conditions
- Cardiac Arrest
- Being tested
- NEWS2 score
- Keywords
- Cardiac arrest, Ambulance, Triage, Deterioration
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEWS2 scoreDiagnostic test
Patients seen by ambulance crews within the preceeding 48 hrs of their cardiac arrest will have a NEWS2 score performed to assess the level of physiological deterioration at the time of thei intial assessment.
| Study group | Role | What they receive |
|---|---|---|
| Out-of-hospital cardiac arrest | Patients suffering an out-of-hospital cardiac arrest to who the ambulance service was requested to attend. Receives: Diagnostic Test: NEWS2 score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Out-of-hospital cardiac arrest
Cardiac arrest following ambulance assessment
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 Feb 2018
- Primary completion19 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- South Central Ambulance Service NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Charles D Deakin, MD, Principal investigator, Divisional Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604639
- Sponsor's protocol ID
- 3724/18
- Status last verified
- Feb 2020
- First submitted
- 21 Oct 2020
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Patients Suffering an Out-of-hospital Cardiac Arrest Present to the Ambulance Service With Symptoms in the Preceeding 48hrs?
- ClinicalTrials.gov ID
- NCT04604639
- Acronym / sponsor ID
- 3724/18
- Conditions
- Cardiac Arrest
- Keywords
- Cardiac arrest, Ambulance, Triage, Deterioration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- South Central Ambulance Service NHS Foundation Trust
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A cardiac arrest is often preceeded by a varying period of physiological deterioration which if acted upon may prevent the cardiac arrest. We aim to review patients presenting to the ambulance service with cardiac arrest so see if they had contacted the ambulance service in the preceeding 48 hrs to understand if warning symptoms were missed or not acted upon appropriately.
Detailed description
The UK ambulance services are called to attend 60,000 out-of-hospital cardiac arrests (OHCA) each year. Hospital studies have shown that many patients who suffer an in-hospital cardiac arrest (IHCA) have been deteriorating for the preceeding 48 hrs and suggest that many IHCA are potentially avoidable if this deterioration is identified and actued on promptly. No similar study has been performed to see if patients suffering OHCA have also presented with warning signs in the preceeding 48 hrs that were overlooked.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Out-of-hospital cardiac arrest | – | Diagnostic Test: NEWS2 scorePatients suffering an out-of-hospital cardiac arrest to who the ambulance service was requested to attend. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients calling for an emergency ambulance in the South Central Ambulance Service region, where an emergency ambulnace was dispatched and a patient intervention occurred.
Key inclusion criteria (1 listed)
- All patients seen by SCAS ambulance crews and suffering a cardiac arrest within the following 48 hrs
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEWS2 scorePatients seen by ambulance crews within the preceeding 48 hrs of their cardiac arrest will have a NEWS2 score performed to assess the level of physiological deterioration at the time of thei intial assessment. | Diagnostic test | Out-of-hospital cardiac arrest |
Primary outcome
Out-of-hospital cardiac arrest
Time frame: 48 hours
Cardiac arrest following ambulance assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles D Deakin, MD principal investigator
Divisional Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Out-of-hospital cardiac arrest (time frame: 48 hours). 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 13 Apr 2022.