Death, Sudden, Cardiac, Tachycardia, Ventricular, Ventricular Fibrillation
Conditions
Keywords
Randomized Controlled Trials, Defibrillators, Medical Devices
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.
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 tachycardia/ventricular fibrillation (VT/VF). Pulseless ventricular tachycardia/ventricular 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 VT/VF the probability of successful defibrillation and subsequent survival to hospital discharge is directly and negatively related to the interval between onset of VT/VF 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 VT/VF 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 3,000 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.
Interventions
DEVICEDefibrillation of pulseless VT/VF by AECD
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.
Sponsors
Emory University
Foundation for Atlanta Veterans Education and Research, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Without Defibrillation | 10 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Participant flow
Recruitment details
One hundred and ninety two patients were recruited in the time period between 10/10/2006 to 7/20/2007 to the telemetry ward of the Atlanta VA Medical Center.
Participants by arm
| Arm | Count |
|---|---|
| No Intervention: Standard of Care Group Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention. | 97 |
| Experimental: AECD Monitoring + Standard of Care Group Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital. | 95 |
| Total | 192 |
Baseline characteristics
| Characteristic | No Intervention: Standard of Care Group | Experimental: AECD Monitoring + Standard of Care Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 97 Participants | 95 Participants | 192 Participants |
| Age, Continuous | 62 years STANDARD_DEVIATION 3.4 | 61.7 years STANDARD_DEVIATION 3.4 | 61.9 years STANDARD_DEVIATION 3.4 |
| Clinical Characteristics of Study Subjects Diabetes mellitus | 35 participants | 46 participants | 81 participants |
| Clinical Characteristics of Study Subjects History of Coronary Artery Disease | 42 participants | 35 participants | 77 participants |
| Clinical Characteristics of Study Subjects History of Heart Failure | 20 participants | 25 participants | 45 participants |
| Clinical Characteristics of Study Subjects Hyperlipidemia | 53 participants | 55 participants | 108 participants |
| Clinical Characteristics of Study Subjects Hypertension | 74 participants | 79 participants | 153 participants |
| Clinical Characteristics of Study Subjects New Diagnosis of Heart Failure | 4 participants | 6 participants | 10 participants |
| EKG on admission Atrial fibrillation/flutter | 11 participants | 9 participants | 20 participants |
| EKG on admission normal sinus rhythm | 81 participants | 84 participants | 165 participants |
| EKG on admission Other | 3 participants | 2 participants | 5 participants |
| EKG on admission supraventricular tachycardia | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Black | 44 participants | 51 participants | 95 participants |
| Race/Ethnicity, Customized Hispanic | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized White | 53 participants | 42 participants | 95 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 94 Participants | 92 Participants | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 95 | 0 / 97 |
| serious Total, serious adverse events | 0 / 95 | 0 / 97 |
Outcome results
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.
Time frame: 10 minutes
Population: There was only one patient in the Intervention group who received defibrillation.~No patients had CPR or defibrillation in the standard of care group.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Experimental: AECD Monitoring + Stand of Care Group | Number of Participants Without Defibrillation | 94 participants | 50 |
| No Intervention: Standard of Care Group | Number of Participants Without Defibrillation | 97 participants | — |
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.
Time frame: At discharge
Population: Only 1 patient in the Intervention group had defibrillation during hospital admission and his CPC was 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: AECD Monitoring + Stand of Care Group | Cerebral Performance at Discharge | 1 units on a scale: CPC 1 |
Secondary
Frequency of Abnormal Rhythms Monitored by the AECD
Time frame: During the duration of hospital admission on the telemetry ward.
Population: Only the AECD+Standard of Care Group was monitored in this portion of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: AECD Monitoring + Stand of Care Group | Frequency of Abnormal Rhythms Monitored by the AECD | Atrial Fibrillation/Flutter | 9 participants |
| Experimental: AECD Monitoring + Stand of Care Group | Frequency of Abnormal Rhythms Monitored by the AECD | Supraventricular Tachycardia | 1 participants |
| Experimental: AECD Monitoring + Stand of Care Group | Frequency of Abnormal Rhythms Monitored by the AECD | Premature Ventricular Complexes | 10 participants |
| Experimental: AECD Monitoring + Stand of Care Group | Frequency of Abnormal Rhythms Monitored by the AECD | Non-Sustained Ventricular Tachycardia | 5 participants |
Secondary
Survival to Discharge
Time frame: At discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: AECD Monitoring + Stand of Care Group | Survival to Discharge | 95 participants |
| No Intervention: Standard of Care Group | Survival to Discharge | 97 participants |