Condition category
Circulatory System
Date applied
07/01/2008
Date assigned
20/03/2008
Last edited
19/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andreas Hoeft

ORCID ID

Contact details

Universitätsklinikum Bonn
Klinik für Anästhesiologie und Operative Intensivmedizin
Sigmund-Freud-Str 25
Bonn
53105
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Automatic chest compressions by the AUTOpulse® resuscitation system versus conventional manual chest compressions in resuscitation from pre-hospital cardiac arrest: a prospective randomised pre-clinical trial in a GERman emergency medical system

Acronym

German ART

Study hypothesis

Resuscitation with the Autopulse® resuscitation system effects both a better primary and a better long term outcome after pre-hospital cardiac arrest.

Please note that as of 28/11/2008 the public title and acronym fields have been updated. The initial details were as follows:
Initial public title: Automatic chest compressions by the Autopulse® resuscitation system versus conventional manual chest compressions in resuscitation from pre-hospital cardiac arrest
Initial acronym: AUTOGER

As of 19/11/2010 this record has been updated and the public title changed to the above; the previous public title was 'German Autopulse Resuscitation Trial'. At this time, the anticipated end date was also amended; the previous end date was 09/01/2010. The target number of participants was extended from 200 to 250 - 300 participants. All other changes can be found in the relevant section.

Ethics approval

1. Independent Ethics Board of the University of Bonn (Germany) on the 13th September 2007 (ref: 099/06)
2. Independent Ehtics Board of th Medical Association of North Rhine (Duesseldorf, Germany) on the 1st April 2008 (ref: 2008068) (added 28/11/2008).

Study design

Prospective, single centre, pre-clinical, randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pre-hospital cardiac arrest

Intervention

The participants will be randomised into the intervention and control groups. Both groups will receive advanced cardiac life support in accordance with the 2005 European Resuscitation Council Guidelines.

Intervention group: chest compressions by the Autopulse® resuscitation system
Control group: manual chest compressions

In addition to the intervention and control groups, a subgroup "fast Autopulse®" will be identified for the analysis of primary and secondary outcome measures. A "fast Autopulse®" patient is defined as a patient who received the first Autopulse® compression less than six minutes of the arrival of the first clinical staff at the site.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Rate of admission to hospital with a spontaneous heart rhythm and a palpable pulse.

Secondary outcome measures

Current infomation as of 19/11/2010:
The following will be analysed for the three patient groups described above:
1. 24-hours survival
2. Rate of discharge from intensive care unit
3. Rate of discharge from hospital
3. Three-month survival
5. One-year survival
6. Overall and neurological performance at these four defined points of time

Initial information at time of registration:
The following will be analysed for the three patient groups described above:
1. Rate of discharge from intensive care unit
2. Rate of discharge from hospital
3. Three-month survival
4. One-year survival
5. Overall and neurological performance at these four defined points of time

Overall trial start date

10/01/2008

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients of the emegency medical system with resuscitation from pre-clinical cardiac arrest of non-traumatic origin
2. Both genders
3. Aged 18 - 80 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

250 - 300 (as of 19/11/2010, previously 200)

Participant exclusion criteria

1. Cardiac arrest of traumatic origin
2. Aged less than 18 or greater than 80 years (known or estimated)
3. Extreme adiposity (estimated chest circumference greater than 150 cm or estimated weight greater than 150 kg)
4. Pregnancy (known or visually noticeable)
5. Time taken from 112 call to physician's arrival at the site greater than 15 minutes

Recruitment start date

10/01/2008

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Germany

Trial participating centre

Universitätsklinikum Bonn
Bonn
53105
Germany

Sponsor information

Organisation

University of Bonn (Germany)

Sponsor details

c/o Dr M Breil
Rheinische Friedrich-Wilhelms-Universität
Universitätsklinikum
Klinik für Anästhesiologie
Sigmund-Freud-Str. 25
Bonn
53105
Germany

Sponsor type

University/education

Website

http://www.uni-bonn.de

Funders

Funder type

University/education

Funder name

University of Bonn (Germany) - Department of Anaesthesiology and Intensive Care Medicine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes