NCT02932124

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
19,609

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

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

January 1, 2007

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

7.9 years

First QC Date

October 6, 2016

Last Update Submit

October 11, 2016

Conditions

Keywords

German Resuscitation Registryout-of-hospital cardiac arrestcardiopulmonary resuscitationmechanical chest compression devices

Outcome Measures

Primary Outcomes (1)

  • return of spontaneous circulation

    sustained return of spontaneous circulation at any time during CPR

    sustained ROSC at any time latest after 24 hours

Study Arms (2)

1

manual chest compressions

2

mechanical chest compression

Device: mechanical chest compression device

Interventions

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Jan Wnent, MD

    German Resuscitation Registry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr.

Study Record Dates

First Submitted

October 6, 2016

First Posted

October 13, 2016

Study Start

January 1, 2007

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 13, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share