NCT04485390

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

October 5, 2021

Status Verified

September 1, 2021

Enrollment Period

5.8 years

First QC Date

July 21, 2020

Last Update Submit

September 27, 2021

Conditions

Keywords

cardiac arrestcardiopulmonary resuscitationautomated external defibrillatorfirst responders

Outcome Measures

Primary Outcomes (3)

  • Return of spontaneous circulation (ROSC)

    The number of patients who gained the ROSC.

    5 years

  • Survival to hospital discharge

    The number of patients who survived to hospital discharge.

    5 years

  • Neurological outcome

    The number of patients with good neurological outcome assessed with cerebral performance score (CPC 1-2).

    5 years

Secondary Outcomes (2)

  • Survival till hospital admission

    5 years

  • 30 day survival

    5 years

Study Arms (2)

First responder group

Cardiac arrest victims in remote areas resuscitated by the first responders before the arrival of the EMS.

Other: Basic life support witn use of an AED before EMS

EMS groups

Cardiac arrest victims in remote areas resuscitated by the EMS.

Interventions

BLS performance with use of an AED before arrival of EMS

First responder group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In the study will be included all adult cardiac arrest victims in the remote areas.

You may qualify if:

  • cardiac arrest in adult victims

You may not qualify if:

  • cardiac arrest in pediatric population

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Death, Sudden, CardiacHeart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Professor

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 24, 2020

Study Start

March 1, 2014

Primary Completion

December 31, 2019

Study Completion

August 31, 2021

Last Updated

October 5, 2021

Record last verified: 2021-09