Cardiac Arrest, SuddenNCT04485390
Impact of the Organization of the First Responders in the Remote Areas on Cardiac Arrest Victim Survival
An observational study of Cardiac Arrest, Sudden, run by University Medical Centre Maribor.
Trial summary
Emergency medical services (EMS) provide emergency care not only in the urban but also in the remote areas which could be up to 40 minutes from the EMS station. Thus, a cardiac arrest victim in those remote areas has a low likelihood to survive the cardiopulmonary resuscitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Sudden
- What is being tested?
- Basic life support witn use of an AED before EMS
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2014to 31 Aug 2021
- 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
- Adult, Older adult
Study population: In the study will be included all adult cardiac arrest victims in the remote areas.
Who may be able to join
- cardiac arrest in adult victims
Who cannot join
- cardiac arrest in pediatric population
About this study
Official title: Impact of the Organization of the First Responders in the Remote Areas on Cardiac Arrest Victim Survival: an Utstein Analysis
Emergency medical services (EMS) provide emergency care not only in the urban but also in the remote areas which could be up to 40 minutes from the EMS station. Thus, a cardiac arrest victim in those remote areas has a low likelihood to survive the cardiopulmonary resuscitation. Therefore, we have organized first responders (who are mostly volunteer fire-fighters) in the remote areas and taught them how to perform basic life support (BLS) with use of an automated external defibrillator (AED). In the case of a cardiac arrest the medical dispatcher activates simultaneously the EMS and the first responders, who perform the BLS with the use of an AED before the arrival of EMS.
The aim of the study is to analyze and compare the survival of the cardiac arrest victims in remote areas in the time period when the first responders were not organized yet compared to the time period when the first responders were activated to perform BLS.
- Conditions
- Cardiac Arrest, Sudden
- Being tested
- Basic life support witn use of an AED before EMS
- Keywords
- cardiac arrest, cardiopulmonary resuscitation, automated external defibrillator, first responders
- Medical subject headings
- Death, Sudden, Cardiac, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic life support witn use of an AED before EMSOther
BLS performance with use of an AED before arrival of EMS
| Study group | Role | What they receive |
|---|---|---|
| First responder group | Cardiac arrest victims in remote areas resuscitated by the first responders before the arrival of the EMS. Receives: Other: Basic life support witn use of an AED before EMS | |
| EMS groups | Cardiac arrest victims in remote areas resuscitated by the EMS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return of spontaneous circulation (ROSC)
The number of patients who gained the ROSC.
Measured: 5 years
Survival to hospital discharge
The number of patients who survived to hospital discharge.
Measured: 5 years
Neurological outcome
The number of patients with good neurological outcome assessed with cerebral performance score (CPC 1-2).
Measured: 5 years
Secondary outcomes (2)
Survival till hospital admission
The number of patients who survived to hospital admission.
Measured: 5 years
30 day survival
The number of patients who survived first 30 days after cardiac arrest.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Mar 2014
- Primary completion31 Dec 2019
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest, SuddenStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matej Strnad, University Medical Centre Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485390
- Sponsor's protocol ID
- UKC-MB-KME-24/20
- Status last verified
- Sep 2021
- First submitted
- 21 Jul 2020
- Last updated
- 5 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Organization of the First Responders in the Remote Areas on Cardiac Arrest Victim Survival: an Utstein Analysis
- ClinicalTrials.gov ID
- NCT04485390
- Acronym / sponsor ID
- UKC-MB-KME-24/20
- Conditions
- Cardiac Arrest, Sudden
- Keywords
- cardiac arrest, cardiopulmonary resuscitation, automated external defibrillator, first responders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Medical Centre MariborUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 24 Jul 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.
Emergency medical services (EMS) provide emergency care not only in the urban but also in the remote areas which could be up to 40 minutes from the EMS station. Thus, a cardiac arrest victim in those remote areas has a low likelihood to survive the cardiopulmonary resuscitation. Therefore, we have organized first responders (who are mostly volunteer fire-fighters) in the remote areas and taught them how to perform basic life support (BLS) with use of an automated external defibrillator (AED). In the case of a cardiac arrest the medical dispatcher activates simultaneously the EMS and the first responders, who perform the BLS with the use of an AED before the arrival of EMS.
The aim of the study is to analyze and compare the survival of the cardiac arrest victims in remote areas in the time period when the first responders were not organized yet compared to the time period when the first responders were activated to perform BLS.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First responder group | – | Other: Basic life support witn use of an AED before EMSCardiac arrest victims in remote areas resuscitated by the first responders before the arrival of the EMS. |
| EMS groups | – | –Cardiac arrest victims in remote areas resuscitated by the EMS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- In the study will be included all adult cardiac arrest victims in the remote areas.
Key inclusion criteria (1 listed)
- cardiac arrest in adult victims
Key exclusion criteria (1 listed)
- cardiac arrest in pediatric population
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 |
|---|---|---|
| Basic life support witn use of an AED before EMSBLS performance with use of an AED before arrival of EMS | Other | First responder group |
Primary outcome
Return of spontaneous circulation (ROSC)
Time frame: 5 years
The number of patients who gained the ROSC.
Survival to hospital discharge
Time frame: 5 years
The number of patients who survived to hospital discharge.
Neurological outcome
Time frame: 5 years
The number of patients with good neurological outcome assessed with cerebral performance score (CPC 1-2).
2 secondary outcomes
Survival till hospital admission
Time frame: 5 years
30 day survival
Time frame: 5 years
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 5 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, Sudden, run by University Medical Centre Maribor.
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 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Return of spontaneous circulation (ROSC) (time frame: 5 years). The study lists 3 primary outcomes in all. 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 5 Oct 2021.