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Comparing Observational Multicentre Prospective Registry Study on Resuscitation

Organizational Data

DRKS-ID:
DRKS00020819
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2020-07-31
Last update in DRKS:
2020-07-31
Registration type:
Retrospective

Acronym/abbreviation of the study

COMPRESS

URL of the study

No Entry

Brief summary in lay language

Mechanical chest compression devices are well established tools for the treatment of out-of-hospital and in-hospital cardiac arrest. The corpuls cpr developed by GS Elektromedizinische Geräte G. Stemple GmbH represents a new generation of mechanical chest compression devices. The COMPRESS study shall observe the usage of the established device. The study examines the chest compression, the ventilation parameters and resuscitation related injuries. The aim of the study is to validate the safety and performance of the device and the safety of its usage for the patient. Over a time period of three years, routine resuscitation data are collected within several emergency medical services based on the German Resuscitation Registry database for this multicenter observational study.

Brief summary in scientific language

Today mechanical chest compression devices are a well-established alternative to manual chest compressions. They are recommended especially within ongoing cardiopulmonary resuscitation (CPR) during transport or special interventions (e.g. coronary angiography). The corpuls cpr developed by GS Elektromedizinische Geräte G. Stemple GmbH represents a new generation of mechanical chest compression devices. The study examines the chest compression (e.g. no-flow-time, pauses, compression depth, compression frequency), the ventilation parameters and resuscitation related injuries. The aim of the study is to validate the safety and performance of the device and the safety of its usage for the patient. Over a time period of three years, routine resuscitation data are collected within several emergency medical services based on the German Resuscitation Registry database for this multicenter observational study. Within the study period yearly interim analyses will be performed.

Health condition or problem studied

ICD10:
I46.9 - Cardiac arrest, unspecified
Free text:
Out-of-hospital cardiopulmonary resuscitation
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Patients are treated as recommended by the guidelines of the European Rescuscitation Council, but chest compressions are exclusively performed manual.
Arm 2:
Patients are treated as recommended by the guidelines of the European Rescuscitation Council, chest compressions are performed at some time with the corpuls cpr

Endpoints

Primary outcome:
24h-survival
Secondary outcome:
30d-survival or hospital discharge

Study Design

Purpose:
Treatment
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Other Rettungsdienst Dortmund
  • Other Rettungsdienst Gütersloh
  • Other Rettungsdienst Aachen
  • Other Rettungsdienst Göppingen

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2020-01-01
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
6600
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
8 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
out-of-hospital cardiac arrest with resuscitation

Exclusion Criteria

traumatic cardiac arrest

Addresses

Primary Sponsor

GS Elektromedizinische Geräte G. Stemple GmbH
Hauswiesenstraße 26
86916 Kaufering
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://corpuls.world
Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

Universitätsklinikum Schleswig-Holstein, Institut für Rettungs- und Notfallmedizin
Prof. Dr. med. Jan-Thorsten Gräsner
Arnold-Heller-Str. 3 Haus 808
24105 Kiel
Germany
Telephone:
043150031551
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uksh.de/Notfallmedizin/

Contact for Public Queries

Universitätsklinikum Schleswig-Holstein, Institut für Rettungs- und Notfallmedizin
Prof. Dr. med. Jan-Thorsten Gräsner
Arnold-Heller-Str. 3 Haus 808
24105 Kiel
Germany
Telephone:
043150031551
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uksh.de/Notfallmedizin/

Principal Investigator

Universitätsklinikum Schleswig-Holstein, Institut für Rettungs- und Notfallmedizin
Prof. Dr. med. Jan-Thorsten Gräsner
Arnold-Heller-Str. 3 Haus 808
24105 Kiel
Germany
Telephone:
043150031551
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uksh.de/Notfallmedizin/

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

GS Elektromedizinische Geräte G. Stemple GmbH
Hauswiesenstraße 26
86916 Kaufering
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://corpuls.world

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Medizinischen Fakultät der Christian-Albrechts-Universität zu Kiel
Schwanenweg 20
24105 Kiel
Germany
Telephone:
+49-431-50014191
Fax:
+49-431-50014195
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2019-01-29
Ethics committee number:
D 422/19
Vote of the Ethics Committee:
Approved
Date of the vote:
2019-08-28

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry