Application of Mechanical Cardiopulmonary Resuscitation Devices and Their Value in Out-of-hospital Cardiac Arrest: A Retrospective Analysis of the German Resuscitation Registry

October 11, 2016 updated by: Jan-Thorsten Graesner, MD, German Resuscitation Registry
The aim of this study was to analyse a large CPR database, the German Resuscitation Registry, to evaluate potential benefits of mechanical CPR devices over manual CPR in adult cardiac arrest victims. The primary endpoint considered is ROSC.

Study Overview

Status

Completed

Detailed Description

In a retrospective analysis of the German Resuscitation Registry between 2007-2014, investigators examined the outcome after using mechanical CPR on return of spontaneous circulation (ROSC) in adults with out-of-hospital cardiac arrest (OHCA). Investigators compared mechanical CPR (Intervention group) to manual CPR (control group). According to preclinical risk factors, investigators calculated the predicted ROSC-after-cardiac-arrest (RACA) score for each group, and compared it to the rate of ROSC observed. Using multivariate analysis, investigators adjusted the influence of the devices' application on ROSC for epidemiological factors and therapeutic measures.

Study Type

Observational

Enrollment (Actual)

19609

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient suffering OHCA and be resuscitated by EMS where the data were delivered to the German Resuscitation Registry

Description

Inclusion Criteria:

  • out of hospital cardiac arrest
  • during time prod from January 2007 until December 2014
  • CPR attempted

Exclusion Criteria:

  • Investigators excluded cases in which CPR was continued for less than five minutes, or duration of CPR was missing, as the outcome in this early period is not affected by the CPR mode.
  • Children aged less than 18 years and patients of unknown age were also excluded as the devices are not approved for resuscitation on children.
  • An active compression-decompression (ACD) is a hand-held suction device, to compress and actively decompress the chest after each compression.
  • Investigators also excluded cases where ACD CPR was used, because it constitutes a different technology.
  • Cases due to trauma were excluded as application of mechanical CPR devices may be limited due in traumatic events.
  • Cases where data on ROSC and/or CPR mode was missing were also excluded.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
manual chest compressions
2
mechanical chest compression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
return of spontaneous circulation
Time Frame: sustained ROSC at any time latest after 24 hours
sustained return of spontaneous circulation at any time during CPR
sustained ROSC at any time latest after 24 hours

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Jan Wnent, MD, German Resuscitation Registry

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

January 1, 2007

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 6, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 11, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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