Ventricular Fibrillation Clinical Trial
Official title:
Automatic External Defibrillation Monitoring in Cardiac Arrest
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.
Status | Completed |
Enrollment | 192 |
Est. completion date | September 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All patients admitted to telemetry ward and emergency department - Age > 18 years. Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Atlanta Veterans Adminstration Medical Center | Decatur | Georgia |
Lead Sponsor | Collaborator |
---|---|
Atlanta Research and Education Foundation | Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Frequency of Abnormal Rhythms Monitored by the AECD | During the duration of hospital admission on the telemetry ward. | No | |
Secondary | Survival to Discharge | At discharge | No | |
Secondary | Cerebral Performance at Discharge | Cerebral Performance Categories/CPC scale: CPC 1: Good cerebral performance - conscious, alert, able to work, might have mild neurologic or psychological deficit. CPC 2: Moderate cerebral disability - conscious, sufficient cerebral function for independent activities of daily life. Able to work in sheltered environment. CPC 3: Severe cerebral disability - conscious, dependent on others for daily support because of impaired brain function. Ranges from ambulatory state to severe dementia or paralysis. CPC 4: Coma or vegetative state - any degree of coma without the presence of all brain death criteria. Unawareness, even if appears awake (vegetative state) without interaction with environment; may have spontaneous eye opening and sleep/awake cycles. Cerebral unresponsiveness. CPC 5: Brain death - apnea, areflexia, electroencephalogram (EEG) silence, etc. |
At discharge | No |
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