Out-of-hospital Cardiac ArrestNCT02932124
Application of Mechanical Cardiopulmonary Resuscitation Devices and Their Value in Out-of-hospital Cardiac Arrest: A Retrospective Analysis of the German Resuscitation Registry
An observational study of Out-of-hospital Cardiac Arrest, run by German Resuscitation Registry.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-hospital Cardiac Arrest
- What is being tested?
- mechanical chest compression device
- Type of treatment
- Medical device
- How many people
- 19,609 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Dec 2014
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient suffering OHCA and be resuscitated by EMS where the data were delivered to the German Resuscitation Registry
Who may be able to join
- out of hospital cardiac arrest
- during time prod from January 2007 until December 2014
- CPR attempted
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Out-of-hospital Cardiac Arrest
- Being tested
- mechanical chest compression device
- Keywords
- German Resuscitation Registry, out-of-hospital cardiac arrest, cardiopulmonary resuscitation, mechanical chest compression devices
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical chest compression deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| 1 | manual chest compressions | |
| 2 | mechanical chest compression Receives: Device: mechanical chest compression device |
What is being measured
The primary outcome is the main question the study is designed to answer.
return of spontaneous circulation
sustained return of spontaneous circulation at any time during CPR
Measured: sustained ROSC at any time latest after 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startJan 2007
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-of-hospital Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19,609 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- German Resuscitation Registry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan-Thorsten Graesner, MD, German Resuscitation Registry
- Investigators
- Jan Wnent, MD, Principal investigator, German Resuscitation Registry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932124
- Sponsor's protocol ID
- GRR-CC07-14
- Status last verified
- Oct 2016
- First submitted
- 6 Oct 2016
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02932124
- Acronym / sponsor ID
- GRR-CC07-14
- Conditions
- Out-of-hospital Cardiac Arrest
- Keywords
- German Resuscitation Registry, out-of-hospital cardiac arrest, cardiopulmonary resuscitation, mechanical chest compression devices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,609 participants (actual)
- Lead sponsor
- German Resuscitation RegistryUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –manual chest compressions |
| 2 | – | Device: mechanical chest compression devicemechanical chest compression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient suffering OHCA and be resuscitated by EMS where the data were delivered to the German Resuscitation Registry
Key inclusion criteria (3 listed)
- out of hospital cardiac arrest
- during time prod from January 2007 until December 2014
- CPR attempted
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mechanical chest compression device | Device | 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Wnent, MD principal investigator
German Resuscitation Registry
Questions about this trial
What is this clinical trial studying?
An observational study of Out-of-hospital Cardiac Arrest, run by German Resuscitation Registry.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
return of spontaneous circulation (time frame: sustained ROSC at any time latest after 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2016.