Automatic External Defibrillation Monitoring in Cardiac Arrest

• Sponsor: Foundation for Atlanta Veterans Education and Research, Inc. (Other)
• Overall Status: Completed
• CT.gov ID: NCT00382928
• Collaborator: Emory University (Other)
• Enrollment: 192
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 5.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Death, Sudden, Cardiac; Ventricular Fibrillation; Tachycardia, Ventricular	Device: Defibrillation of pulseless VT/VF by AECD	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 192 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Automatic External Defibrillation Monitoring in Cardiac Arrest
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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
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. Defibrillation of pulseless VT/VF by AECD.	Device: Defibrillation 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Frequency of Abnormal Rhythms Monitored by the AECD [During the duration of hospital admission on the telemetry ward.]

2. Survival to Discharge [At discharge]

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atlanta Veterans Adminstration Medical Center	Decatur	Georgia	United States	30033

Sponsors and Collaborators

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

Investigators

• Principal Investigator: A. Maziar Zafari, M.D., Ph.D, Division of Cardiology, Atlanta Veterans Adminstration Medical Center/ Emory University, Decatur, GA

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: A. Maziar Zafari, Chief, Cardiology, Atlanta VA Medical Center
• ClinicalTrials.gov Identifier: NCT00382928
• Other Study ID Numbers: 1216-2004
• First Posted: Oct 2, 2006
• Last Update Posted: Jul 15, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by A. Maziar Zafari, Chief, Cardiology, Atlanta VA Medical Center: Randomized Controlled Trials; Defibrillators; Medical Devices
• Additional relevant MeSH terms: Heart Arrest; Tachycardia; Ventricular Fibrillation; Death, Sudden, Cardiac; Tachycardia, Ventricular; Death, Sudden

Study Results

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.

Arm/Group Title	No Intervention: Standard of Care Group	Experimental: AECD Monitoring + Standard of Care Group
Arm/Group Description	Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention	Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
Period Title: Overall Study
STARTED	97	95
COMPLETED	97	95
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	No Intervention: Standard of Care Group	Experimental: AECD Monitoring + Standard of Care Group	Total
Arm/Group Description	Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.	Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.	Total of all reporting groups
Overall Participants	97	95	192
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	97 100%	95 100%	192 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62 (3.4)	61.7 (3.4)	61.9 (3.4)
Sex: Female, Male (Count of Participants)
Female	3 3.1%	3 3.2%	6 3.1%
Male	94 96.9%	92 96.8%	186 96.9%
Race/Ethnicity, Customized (participants) [Number]
Hispanic	0 0%	2 2.1%	2 1%
White	53 54.6%	42 44.2%	95 49.5%
Black	44 45.4%	51 53.7%	95 49.5%
Clinical Characteristics of Study Subjects (participants) [Number]
History of Heart Failure	20 20.6%	25 26.3%	45 23.4%
New Diagnosis of Heart Failure	4 4.1%	6 6.3%	10 5.2%
Diabetes mellitus	35 36.1%	46 48.4%	81 42.2%
History of Coronary Artery Disease	42 43.3%	35 36.8%	77 40.1%
Hypertension	74 76.3%	79 83.2%	153 79.7%
Hyperlipidemia	53 54.6%	55 57.9%	108 56.3%
EKG on admission (participants) [Number]
normal sinus rhythm	81 83.5%	84 88.4%	165 85.9%
Atrial fibrillation/flutter	11 11.3%	9 9.5%	20 10.4%
supraventricular tachycardia	2 2.1%	0 0%	2 1%
Other	3 3.1%	2 2.1%	5 2.6%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Without Defibrillation
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Experimental: AECD Monitoring + Stand of Care Group	No Intervention: Standard of Care Group
Arm/Group Description	Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.	Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
Measure Participants	95	97
Number [participants]	94 (50) 96.9%	97 102.1%

2. Secondary Outcome

Title	Frequency of Abnormal Rhythms Monitored by the AECD
Time Frame	During the duration of hospital admission on the telemetry ward.

Outcome Measure Data

Analysis Population Description

Only the AECD+Standard of Care Group was monitored in this portion of the study.

Arm/Group Title	AECD Monitoring + Standard of Care Group	Standard of Care
Arm/Group Description	Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.	Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
Measure Participants	95	0
Atrial Fibrillation/Flutter	9 9.3%
Supraventricular Tachycardia	1 1%
Premature Ventricular Complexes	10 10.3%
Non-Sustained Ventricular Tachycardia	5 5.2%

3. Secondary Outcome

Title	Survival to Discharge
Time Frame	At discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental: AECD Monitoring + Standard of Care Group	No Intervention: Standard of Care
Arm/Group Description	Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.	Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
Measure Participants	95	97
Number [participants]	95 97.9%	97 102.1%

4. Secondary Outcome

Title	Cerebral Performance at Discharge
Description	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

Outcome Measure Data

Analysis Population Description

Only 1 patient in the Intervention group had defibrillation during hospital admission and his CPC was 1.

Arm/Group Title	AECD Monitoring + Standard of Care Group	Standard of Care Group
Arm/Group Description	Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.	Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
Measure Participants	1	0
Number [units on a scale: CPC 1]	1

Adverse Events

Arm/Group Title	Experimental: AECD Monitoring + Standard of Care Group		No Intervention: Standard of Care Group
Arm/Group Description	Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.		Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
All Cause Mortality
	Experimental: AECD Monitoring + Standard of Care Group		No Intervention: Standard of Care Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Experimental: AECD Monitoring + Standard of Care Group		No Intervention: Standard of Care Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/95 (0%)		0/97 (0%)
Other (Not Including Serious) Adverse Events
	Experimental: AECD Monitoring + Standard of Care Group		No Intervention: Standard of Care Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/95 (10.5%)		0/97 (0%)
Cardiac disorders
False Positive Events in which, the shocks were delivered inappropriately.	2/95 (2.1%)	2	0/97 (0%)	0
Anxiety	2/95 (2.1%)	2	0/97 (0%)	0
Skin irritation by the pads	2/95 (2.1%)	2	0/97 (0%)	0
Alarming of the AECD, as the pads detached from the chest wall during sleep	4/95 (4.2%)	4	0/97 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.