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Arrest 8: Maximizing CPR during the use of the Automatic External Defibrillator.


- candidate number2055
- NTR NumberNTR652
- ISRCTNISRCTN72257677
- Date ISRCTN created7-jun-2006
- date ISRCTN requested16-mei-2006
- Date Registered NTR12-apr-2006
- Secondary IDsN/A 
- Public TitleArrest 8: Maximizing CPR during the use of the Automatic External Defibrillator.
- Scientific TitleIncreasing survival in patients with out-of-hospital cardiac arrest (OHCA) by maximizing the administration of CPR during the use of the Automatic External Defibrillator. A randomized study.
- ACRONYMN/A
- hypothesis1. There is a significant increase in the time spent on chest compressions and rescue breathing using new designed voiceprompts, and 2. There is, similar like in animal studies, a positive trade-off in immediate survival from these changes.
- Healt Condition(s) or Problem(s) studiedOut-of-hospital cardiac arrest (OHCA)
- Inclusion criteriaAll patients in OHCA in the study area, to whom a study-AED is applied, are included in the study.
- Exclusion criteria1. Resuscitations because of trauma; 2. Persons below the age of 8 years; 3. Ambulance already present when circulatory arrest occurs.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jun-2006
- planned closingdate1-jun-2009
- Target number of participants392
- InterventionsAltering the voiceprompts of the AED in such a way that more CPR can be given during resuscitation. Setting of AED (regular voice prompts vs. new voiceprompts cannot be identified before patient is connected to the AED. After that randomization is unblinded as the next voiceprompts are different.
- Primary outcomeAdmission alive in the hospital in ICU or CCU or at intervention procedure, after restoration of spontaneous circulation (ROSC).
- Secondary outcome1. The increase of total time spent on chest compressions and rescue breathing, expressed as % of total connection time of the AED before ROSC; 2. Amount of chest compressions given during the AED connection time before ROSC; 3. Moment of ROOR, cq ROOR during AED use; 4. Rate of recurrence of VF; 5. Discharge alive from the hospital; 6. OPC/CPC score at discharge from the hospital.
- Timepoints
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES J. Berdowski
- CONTACT for SCIENTIFIC QUERIES R.W. Koster
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Medtronic BV.
- PublicationsN/A
- Brief summaryBackground: The use of the AED, paradoxically, proved to be a cause of withholding BLS during substantial periods. Intervention: This information has resulted in voice prompt changes, based on best available evidence. Design: The study aims to improve the use of the AED in patients with out-of-hospital cardiac arrest and the maximal application of chest compressions and ventilations during application of the AED. The study is per-patient randomized and controlled with AEDs with “regular” voiceprompt settings. All patients in out-of-hospital cardiac arrest, to whom a study-AED is applied, are included in the study. Exclusion criteria are resuscitations because of trauma; persons below the age of 8 years (AED not allowed); ambulance already present when circulatory arrest occurs. Endpoint: The primary endpoint of the study is admission alive in the hospital after being stabilized in the field and/or in the Emergency Room. Unblinding is unavoidable at the start of use of the AED, as the “regular” and “experimental” voice prompt design are clearly different. Outcome assessment for the primary outcome therefore is objective but not blinded.
- Main changes (audit trail)
- RECORD12-apr-2006 - 3-jul-2006


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