Sex-unique Disparities in Survival and Resuscitation After Out-of-hospital Cardiac Arrest - a Danish Analysis

October 13, 2022 updated by: Eleonora Casarini, Prehospital Center, Region Zealand

The goal of this observational study is to investigate characteristics in out-of-hospital cardiac arrests (OHCA) related to sex differences.

The main questions it aims to answer are:

  • are there possible differences in help provision by bystanders, cardiopulmonary resuscitation (CPR), pre-hospital treatment by emergency medical services (EMS)?
  • are there differences in the presence of shockable initial rhythm (SIR) and survival rates after OHCA at successive stages of treatment? Researchers will compare all emergency medical services treated resuscitations in Denmark between 2016 and 2021 to see if there are possible differences between sexes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This analysis will be based on data from the national electronic based Danish OHCA registry. Data on OHCAs with resuscitative attempts in Denmark have been collected in the electronic based Danish Medical Service report system since 2016. The registry covers detailed data including the EMS report, executive entries, and advanced text searches of prehospital charts. All cases go through an elaborate validation process where all identified events are read through manually by an external verification team. This ensures high quality of data, collected according to the Utstein recommendations, throughout the approximately 5400 cases of OHCA in Denmark annually. During this verification process, supplementary sources of data are linked to each OHCA, among others information about survival, localization, initiation of bystander CPR and EMS personnel operation.

Study Type

Observational

Enrollment (Actual)

27000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All emergency medical services treated resuscitations in Denmark between 2016 and 2021 registered in the national electronic based Danish OHCA registry

Description

Inclusion Criteria:

- All emergency medical services treated resuscitations in Denmark between 2016 and 2021

Exclusion Criteria:

- Patients that are found dead at emergency medical service arrival, with sure death indicators such as rigor mortis or livores.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-days survival
Time Frame: 30 days from OHCA
Records on survival after 30 days from cardiac arrest
30 days from OHCA

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiopulmonary Resuscitation (CPR)
Time Frame: 2016-2021
Whether or not CPR was performed on the patient
2016-2021
Presence of shockable initial rhythm (SIR)
Time Frame: 2016-2021
Whether or not a schockable intial rhythm was recorded
2016-2021
Return of spontaneous circulation (ROSC) at any time
Time Frame: 2016-2021
Whether or not there was return of spontaneous circulation at any time
2016-2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prehospital Center, Region Zealand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 17, 2022

Study Record Updates

Last Update Posted (Actual)

October 17, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ohcagd2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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