Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00382928
Status:
COMPLETED
Last Update Posted:
2015-07-15
First Post:
2006-09-29
Brief Title:
Automatic External Defibrillation Monitoring in Cardiac Arrest
Sponsor:
Foundation for Atlanta Veterans Education and Research Inc
Organization:
Foundation for Atlanta Veterans Education and Research Inc
Study Overview
Official Title:
Automatic External Defibrillation Monitoring in Cardiac Arrest
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We propose to randomize automatic external cardioverterdefibrillators 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
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
Detailed Description:
Cardiac arrest CA is defined as the sudden cessation of effective cardiac pumping function as a result of either ventricular asystole inactivity of the heart or pulseless ventricular tachycardiaventricular fibrillation VTVF Pulseless ventricular tachycardiaventricular fibrillation is an abnormal electrical activity of the ventricles of the heart Rapid diagnosis and treatment are essential because first more than a few minutes of total CA results in permanent damage to the brain due to lack of oxygen and second the success of resuscitative measures is related to the rapidity with which they are instituted following arrest For a person in VTVF the probability of successful defibrillation and subsequent survival to hospital discharge is directly and negatively related to the interval between onset of VTVF and delivery of first shock
Comparison By using AECDs we will evaluate if an automatic rapid accurate and specific diagnostic technology will further increase the rate of survival in patients with VTVF by rapid and automatic defibrillation independent of operator initiation as compared to standard cardiopulmonary resuscitation CPR with conventional defibrillators initiated by healthcare providers This trial will be a randomized controlled trial and will test if AECDs can improve outcome measures when compared to traditional responses
Conventional defibrillators are manually operated defibrillators that have to be attached to the patient and operated by a healthcare provider or layperson In contrast the purpose of AECDs is to automatically detect life-threatening arrhythmias and deliver external shocks according to a programmable prescription for hospitalized patients who may be at transient risk for the development of life-threatening arrhythmias AECDs immediately and automatically monitor detect and treat cardiac arrhythmias with no human intervention The AECD proposed to be utilized in this trial PowerHeart CRM a product of Cardiac Science Inc has been evaluated in the hospital setting to assess safety and efficacy and has been approved by the FDA to be prophylactically attached to hospital patients and provide automatic defibrillation therapy without human intervention
All patients admitted to the telemetry unit will be asked to volunteer for this study Up to 3000 patients will be asked to volunteer in this study during their stay in the telemetry unit This study will evaluate if there is a way to improve survival in CA by comparing two groups
Group 1 This group includes patients admitted to telemetry unit who will undergo standard measures of CPR in case cardiac arrest is suspected
Group 2 This group includes patients admitted to telemetry unit who will have an AECD attached to the chest wall and who will also undergo standard measures of CPR in case of cardiac arrest
Comparison By using AECDs we will evaluate if an automatic rapid accurate and specific diagnostic technology will further increase the rate of survival in patients with VTVF by rapid and automatic defibrillation independent of operator initiation as compared to standard cardiopulmonary resuscitation CPR with conventional defibrillators initiated by healthcare providers This trial will be a randomized controlled trial and will test if AECDs can improve outcome measures when compared to traditional responses
Conventional defibrillators are manually operated defibrillators that have to be attached to the patient and operated by a healthcare provider or layperson In contrast the purpose of AECDs is to automatically detect life-threatening arrhythmias and deliver external shocks according to a programmable prescription for hospitalized patients who may be at transient risk for the development of life-threatening arrhythmias AECDs immediately and automatically monitor detect and treat cardiac arrhythmias with no human intervention The AECD proposed to be utilized in this trial PowerHeart CRM a product of Cardiac Science Inc has been evaluated in the hospital setting to assess safety and efficacy and has been approved by the FDA to be prophylactically attached to hospital patients and provide automatic defibrillation therapy without human intervention
All patients admitted to the telemetry unit will be asked to volunteer for this study Up to 3000 patients will be asked to volunteer in this study during their stay in the telemetry unit This study will evaluate if there is a way to improve survival in CA by comparing two groups
Group 1 This group includes patients admitted to telemetry unit who will undergo standard measures of CPR in case cardiac arrest is suspected
Group 2 This group includes patients admitted to telemetry unit who will have an AECD attached to the chest wall and who will also undergo standard measures of CPR in case of cardiac arrest
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None