Condition category
Circulatory System
Date applied
07/06/2006
Date assigned
07/06/2006
Last edited
22/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
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
r.w.koster@amc.nl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rudolph Koster

ORCID ID

Contact details

Academic Medical Center (AMC)
Department of Cardiology
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 2608
r.w.koster@amc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR652

Study information

Scientific title

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

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Out-of-hospital cardiac arrest (OHCA)

Intervention

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

Device

Phase

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

01/06/2006

Overall trial end date

31/01/2014

Reason abandoned

Eligibility

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

Patient

Age group

Mixed

Gender

Both

Target number of participants

392

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

01/06/2006

Recruitment end date

31/01/2014

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center (AMC)
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC) (Netherlands)

Sponsor details

PO Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.nl/?pid=2581

Funders

Funder type

Industry

Funder name

Medtronic BV (Netherlands)

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

2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20042768
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27327233

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.