- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02932124
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
Conditions
Intervention / Treatment
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GRR-CC07-14
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.
Clinical Trials on Out-of-hospital Cardiac Arrest
-
Medical University of ViennaLudwig Boltzmann Institute Digital Health and Patient Safety; Emergency Medical...RecruitingCardiac Arrest, Out-Of-HospitalAustria
-
University Medical Centre MariborOHK Medical DevicesRecruiting"The Effect of the Use of an Autotransfusion Device on Hemodynamic Parameters During Resuscitation".Cardiac Arrest | Out of Hospital Cardiac ArrestSlovenia
-
National Taiwan University HospitalRecruitingOut-Of-Hospital Cardiac ArrestTaiwan
-
Far Eastern Memorial HospitalRecruitingOut-Of-Hospital Cardiac ArrestTaiwan
-
King's College LondonKing's College Hospital NHS Trust; London Ambulance Service NHS TrustNot yet recruiting
-
Wroclaw Medical UniversityWroclaw Emergency Medical ServicesRecruiting
-
Sunnybrook Health Sciences CentrePrescott-Russell Paramedic Service; Peterborough Paramedic Service; Bruce County... and other collaboratorsRecruiting
-
Emergency Medical Services, Capital Region, DenmarkTrygFonden, Denmark; Danish Heart Foundation; Zoll Medical CorporationRecruitingOut-Of-Hospital Cardiac ArrestDenmark
-
Guy's and St Thomas' NHS Foundation TrustLondon School of Hygiene and Tropical Medicine; King's College London; King's... and other collaboratorsActive, not recruitingOut-Of-Hospital Cardiac ArrestUnited Kingdom
-
National Taiwan University HospitalCompletedOut-Of-Hospital Cardiac ArrestTaiwan
Clinical Trials on mechanical chest compression device
-
Eskisehir Osmangazi UniversityScientific Research Projects Commission of ESOGUCompletedCardiopulmonary ResuscitationTurkey
-
Institute of Mountain Emergency MedicineCompleted
-
Cedars-Sinai Medical CenterCompleted
-
Children's Hospital of PhiladelphiaCompleted
-
Hanyang UniversityCompletedCardiac Arrest | Cardiopulmonary ResuscitationKorea, Republic of
-
Cairo UniversityCompleted
-
Hanyang UniversityCompletedCardiac ArrestKorea, Republic of
-
Lazarski UniversityThe Cleveland Clinic; Wroclaw Medical UniversityCompleted
-
Assistance Publique - Hôpitaux de ParisRecruiting