Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cardio-pulmonary resuscitation (CPR) is a first aid technique that can be used if someone’s heart has stopped (cardiac arrest). Chest compressions and rescue breathing by lay rescuers and professionals are essential components in saving a victim's life, besides other measures such as defibrillation with an Automated External Defibrillator (AED), a machine that delivers an electric shock to the heart when someone is having a cardiac arrest. Interruptions of chest compressions should be avoided as much as possible. We found in earlier studies that AEDs cause interruptions because they prompt the rescuer what to do with an electronic voice. Among the voice instructions are several moments of stopping chest compressions for heart rhythm analysis and checking the pulse. Analysis of cases revealed that such prompts may not be needed for good CPR. We designed a different set of voice prompts for AEDs that could reduce the hands-off time during CPR and possibly improve outcome.

Who can participate?
All patients in out-of-hospital cardiac arrest in the study area, to whom an AED is applied.

What does the study involve?
The cases will be randomly allocated into two groups. For half of the cases the AED will ‘speak’ the voice prompts as used before, and in the other half of the cases the voice prompts will be of the new kind with less hands-off time. A rescuer employing an AED just follows the voice prompts and that does not change. Only the order of voice prompts is different and some commands are removed.

What are the possible benefits and risks of participating?
The benefit could be more success in bringing back the patient’s pulse and regaining consciousness. Ultimately it should result in more patients admitted alive to the hospital and after that more patients being discharged alive. There are no particular risks to the new procedure compared to the old procedure.

Where is the study run from?
Academic Medical Center (AMC) (Netherlands)

When is the study starting and how long is it expected to run for?
June 2006 to January 2014

Who is funding the study?
Medtronic BV (Netherlands)

Who is the main contact?
Dr Rudolph Koster

Trial website

Contact information



Primary contact

Dr Rudolph Koster


Contact details

Academic Medical Center (AMC)
Department of Cardiology
Meibergdreef 9
1105 AZ
+31 (0)20 566 2608

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Arrest 8: maximizing cardiopulmonary resuscitation (CPR) during the use of the automatic external defibrillator


Study hypothesis

1. There is a significant increase in the time spent on chest compressions and rescue breathing using new designed voice-prompts.
2. There is, similar to animal studies, a positive trade-off in immediate survival from these changes.

Ethics approval

AMC Medical Ethics Committee (Medisch Ethische Commissie AMC), 15/12/2005, MEC 05/195 #05.17.1602

Study design

Randomized controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet

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


Out-of-hospital cardiac arrest (OHCA)


Altering the voice prompts of the AED in such a way that more CPR can be given during resuscitation. Setting of AED regular voice prompts versus new voice prompts cannot be identified before patient is connected to the AED. After that randomization is unblinded as the next voice prompts are different.

Intervention type



Drug names

Primary outcome measures

Admission alive in the hospital in intensive care unit (ICU) or critical care unit (CCU) or at intervention procedure, after restoration of spontaneous circulation (ROSC).

Secondary outcome measures

1. The increase of total time spent on chest compressions and rescue breathing, expressed as a percentage of total connection time of the AED before return of spontaneous circulation (ROSC)
2. Amount of chest compressions given during the AED connection time before ROSC
3. Moment of the return of organized rhythm (ROOR), in this case, ROOR during AED use
4. Rate of recurrence of VF
5. Discharged alive from the hospital
6. Overall performance categories/cerebral performance categories (OPC/CPC) score on discharge from the hospital

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

All patients in out-of-hospital cardiac arrest (OHCA) in the study area, to whom a study automatic external defibrillator (AED) is applied

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Resuscitations because of trauma
2. Persons below the age of 8
3. Ambulance already present when circulatory arrest occurs

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Academic Medical Center (AMC)
1105 AZ

Sponsor information


Academic Medical Center (AMC) (Netherlands)

Sponsor details

PO Box 22660
1100 DD

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Medtronic BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

2010 results in:
2016 results in:

Publication citations

  1. Results

    Berdowski J, Tijssen JG, Koster RW, Chest compressions cause recurrence of ventricular fibrillation after the first successful conversion by defibrillation in out-of-hospital cardiac arrest., Circ Arrhythm Electrophysiol, 2010, 3, 1, 72-78, doi: 10.1161/CIRCEP.109.902114.

  2. Results

    Beesems SG, Berdowski J, Hulleman M, Blom MT, Tijssen JG, Koster RW, Minimizing Pre- and Post-Shock Pauses During the Use of an Automatic External Defibrillator by two Different Voice Prompt protocols. A randomized controlled trial of a bundle of measures, Resuscitation, 2016, S0300-9572(16)30106-X, doi: 10.1016/j.resuscitation.2016.06.009.

Additional files

Editorial Notes

22/06/2016: Publication reference added. 28/05/2014: the overall trial end date was changed from 01/06/2009 to 31/01/2014.