Phase 1
N=192
Automatic External Defibrillation Monitoring in Cardiac Arrest
Death, Sudden, Cardiac · Ventricular Fibrillation · Tachycardia, Ventricular
Bottom Line
View on ClinicalTrials.gov: NCT00382928 ↗Enrolled (actual)
192
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Number of Participants Without Defibrillation — 94; 97 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Defibrillation of pulseless VT/VF by AECD (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Foundation for Atlanta Veterans Education and Research, Inc.
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Without Defibrillation |
94; 97 | — |
| SECONDARY Frequency of Abnormal Rhythms Monitored by the AECD |
9; 1; 10; 5 | — |
| SECONDARY Survival to Discharge |
95; 97 | — |
| SECONDARY Cerebral Performance at Discharge |
1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00382928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.