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

ISRCTN	ISRCTN72257677
DOI	https://doi.org/10.1186/ISRCTN72257677
Secondary identifying numbers	NTR652

Submission date: 07/06/2006
Registration date: 07/06/2006
Last edited: 22/06/2016

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Rudolph Koster
Scientific

Academic Medical Center (AMC)
Department of Cardiology
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 566 2608
Email	r.w.koster@amc.nl

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
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	Arrest 8: maximizing cardiopulmonary resuscitation (CPR) during the use of the automatic external defibrillator
Study objectives	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(s)	AMC Medical Ethics Committee (Medisch Ethische Commissie AMC), 15/12/2005, MEC 05/195 #05.17.1602
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
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 study start date	01/06/2006
Completion date	31/01/2014

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	Both
Target number of participants	392
Key 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
Key exclusion criteria	1. Resuscitations because of trauma 2. Persons below the age of 8 3. Ambulance already present when circulatory arrest occurs
Date of first enrolment	01/06/2006
Date of final enrolment	31/01/2014

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center (AMC)

Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Center (AMC) (Netherlands)
Hospital/treatment centre

PO Box 22660
Amsterdam
1100 DD
Netherlands

Website	http://www.amc.nl/?pid=2581
"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Industry

Medtronic BV (Netherlands)

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2010		Yes	No
Results article	results	01/09/2016		Yes	No

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.