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NCT05583084 Clinical Trial

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

Out-Of-Hospital Cardiac Arrest Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05583084
Other study ID # ohcagd2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date December 31, 2021

Study information
Verified date October 2022
Source Prehospital Center, Region Zealand
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 27000
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Investigation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Prehospital Center, Region Zealand

Outcome
Type Measure Description Time frame Safety issue
Primary 30-days survival Records on survival after 30 days from cardiac arrest 30 days from OHCA
Secondary Cardiopulmonary Resuscitation (CPR) Whether or not CPR was performed on the patient 2016-2021
Secondary Presence of shockable initial rhythm (SIR) Whether or not a schockable intial rhythm was recorded 2016-2021
Secondary Return of spontaneous circulation (ROSC) at any time Whether or not there was return of spontaneous circulation at any time 2016-2021
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