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Arrest 8: maximizing cardiopulmonary resuscitation (CPR) during the use of the automatic external defibrillator
ISRCTN ISRCTN72257677
DOI 10.1186/ISRCTN72257677
ClinicalTrials.gov identifier
EudraCT number
Public title Arrest 8: maximizing cardiopulmonary resuscitation (CPR) during the use of the automatic external defibrillator
Scientific title
Acronym N/A
Serial number at source NTR652
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

On 28/05/2014 the anticipated end date was changed from 01/06/2009 to 31/01/2014.
Lay 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?
The study ran from June 2006 to January 2014.

Who is funding the study?
Medtronic BV (Netherlands).

Who is the main contact?
Dr Rudolph Koster
r.w.koster@amc.nl
Ethics approval AMC Medical Ethics Committee (Medisch Ethische Commissie AMC), 15/12/2005, MEC 05/195 #05.17.1602
Study design Randomized controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Out-of-hospital cardiac arrest (OHCA)
Participants - 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, are included from the study
Participants - exclusion criteria 1. Resuscitations because of trauma
2. Persons below the age of 8
3. Ambulance already present when circulatory arrest occurs
Anticipated start date 01/06/2006
Anticipated end date 31/01/2014
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 392
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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
Sources of funding Medtronic BV (Netherlands)
Trial website
Publications 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20042768
Contact name Dr  Rudolph  Koster
  Address Academic Medical Center (AMC)
Department of Cardiology
Meibergdreef 9
  City/town Amsterdam
  Zip/Postcode 1105 AZ
  Country Netherlands
  Tel +31 (0)20 566 2608
  Fax +31 (0)20 566 9131
  Email r.w.koster@amc.nl
Sponsor Academic Medical Center (AMC) (Netherlands)
  Address P.O. Box 22660
  City/town Amsterdam
  Zip/Postcode 1100 DD
  Country Netherlands
  Sponsor website: http://www.amc.nl/?pid=2581
Date applied 07/06/2006
Last edited 03/06/2014
Date ISRCTN assigned 07/06/2006
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