Plain English Summary
Background and study aims
Cardio-pulmonary resuscitation (CPR) is a first aid technique that can be used if someones 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 patients 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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20042768
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27327233
Publication citations
-
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.
-
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.