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

Out-of-hospital Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02932124
• Other study ID #: GRR-CC07-14
• 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

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

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