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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02932124
Other study ID # GRR-CC07-14
Secondary ID
Status Completed
Phase N/A
First received October 6, 2016
Last updated October 11, 2016
Start date January 2007
Est. completion date December 2014

Study information

Verified date October 2016
Source German Resuscitation Registry
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 19609
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
mechanical chest compression device


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
German Resuscitation Registry

Outcome

Type Measure Description Time frame Safety issue
Primary return of spontaneous circulation sustained return of spontaneous circulation at any time during CPR sustained ROSC at any time latest after 24 hours No
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