German Automatic chest compression Resuscitation Trial

ISRCTN	ISRCTN78354073
DOI	https://doi.org/10.1186/ISRCTN78354073
Secondary identifying numbers	N/A

Submission date: 07/01/2008
Registration date: 20/03/2008
Last edited: 19/11/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Andreas Hoeft
Scientific

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

Study information

Study design	Prospective, single centre, pre-clinical, randomised controlled trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	German ART
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	10/01/2008
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	250 - 300 (as of 19/11/2010, previously 200)
Key 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
Key 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
Date of first enrolment	10/01/2008
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Germany

Study participating centre

Universitätsklinikum Bonn

Bonn
53105
Germany

Sponsor information

University of Bonn (Germany)
University/education

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

Website	http://www.uni-bonn.de
"ROR"	https://ror.org/041nas322

Funders

Funder type

University/education

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan