Automatic External Defibrillation Monitoring in Cardiac Arrest

NCT00382928 | Completed Phase 1 Results DMC

• 1 other identifier: 1216-2004
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

We propose to randomize automatic external cardioverter/defibrillators (AECD) in patients who are at high risk for life-threatening abnormal heart rhythms (arrhythmias) and are admitted to the telemetry ward, all other treatments being constant including cardiopulmonary resuscitation. We hypothesize that the automatic, rapid, accurate and specific diagnostic and therapeutic technology used in AECDs will further increase the rate of survival in patients with cardiac arrest through rapid and automatic defibrillation, independent of operator initiation, as compared to standard cardiopulmonary resuscitation initiated by healthcare providers.

Conditions

Death, Sudden, Cardiac; Ventricular Fibrillation; Tachycardia, Ventricular

Keywords

Randomized Controlled Trials; Defibrillators; Medical Devices

Outcome Measures

Primary Outcomes (1)

• Number of Participants Without Defibrillation

  Time to defibrillation: interval between onset of VT/VF and delivery of first shock. Expected time to defibrillation for AECD group: 30±30 seconds; expected time to defibrillation for Standard of Care group: 180±180.

  10 minutes

Secondary Outcomes (3)

• Frequency of Abnormal Rhythms Monitored by the AECD

  During the duration of hospital admission on the telemetry ward.

• Survival to Discharge

  At discharge

• Cerebral Performance at Discharge

  At discharge

Study Arms (2)

Standard of Care Group

NO INTERVENTION

Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention

AECD Monitoring + Standard of Care Group

EXPERIMENTAL

Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital. Defibrillation of pulseless VT/VF by AECD.

Device: Defibrillation of pulseless VT/VF by AECD

Interventions

Defibrillation of pulseless VT/VF by AECD DEVICE

In case of cardiac arrest caused by shockable rhythms the automatic external cardioverter defibrillator (AECD) will automatically deliver defibrillation. Automated External Cardioverter Defibrillator (AECD; The PowerHeart CRM, Cardiac Science Inc., Seattle, WA) is a device attached to the chest wall by pads, monitors the electrocardiogram, and is capable of automatically delivering electric countershock to appropriate rhythms without operator intervention. The device will deliver only one shock of 150 Joules for pulseless ventricular tachycardia and ventricular fibrillation.

AECD Monitoring + Standard of Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients admitted to telemetry ward and emergency department
• Age \> 18 years.

You may not qualify if:

• Pregnant women
• Patients with R wave less than 0.5 millivolts.
• Patients with functioning Internal Cardiac Device.
• Patients with cardiac pacemakers if oversensing by AECD is demonstrated (double counting of pacer spikes).
• Patients with visible chest lesions that would prevent AECD pad placement.
• Patients who are designated Do Not Resuscitate.
• Right bundle branch block.
• Patients with Parkinson's disease.
• Patients with seizure disorders

Sponsors & Collaborators

• Foundation for Atlanta Veterans Education and Research, Inc.: lead
• Emory University: collaborator

Study Sites (1)

Atlanta Veterans Adminstration Medical Center

Decatur, Georgia, 30033, United States

Location

Related Publications (1)

• Ali B, Bloom H, Veledar E, House D, Norvel R, Dudley SC, Zafari AM. Automated external cardioversion defibrillation monitoring in cardiac arrest: a randomized trial. Trials. 2008 Jun 11;9:36. doi: 10.1186/1745-6215-9-36.

  PMID: 18547438 DERIVED

Related Links

• Click here for detailed information about this study: Automated external cardioversion defibrillation monitoring in cardiac arrest: a randomized trial

MeSH Terms

Conditions

Death, Sudden, Cardiac; Ventricular Fibrillation; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Tachycardia; Cardiac Conduction System Disease

Results Point of Contact

• Title: Dr. A. Maziar Zafari
• Organization: Atlanta Research and Education Foundation

azafari@emory.edu

404-321-6111

Study Officials

• A. Maziar Zafari, M.D., Ph.D

  Division of Cardiology, Atlanta Veterans Adminstration Medical Center/ Emory University, Decatur, GA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Cardiology

Study Record Dates

• First Submitted: September 29, 2006
• First Posted: October 2, 2006
• Study Start: October 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 15, 2015
• Results First Posted: July 1, 2014

Record last verified: 2015-06

Locations

US (1)