Trial Outcomes & Findings for Automatic External Defibrillation Monitoring in Cardiac Arrest (NCT NCT00382928)
NCT ID: NCT00382928
Last Updated: 2015-07-15
Results Overview
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.
COMPLETED
PHASE1
192 participants
10 minutes
2015-07-15
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
95
|
|
Overall Study
COMPLETED
|
97
|
95
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Automatic External Defibrillation Monitoring in Cardiac Arrest
Baseline characteristics by cohort
| Measure |
No Intervention: Standard of Care Group
n=97 Participants
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
n=95 Participants
Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
97 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 3.4 • n=7 Participants
|
61.9 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
53 participants
n=5 Participants
|
42 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
44 participants
n=5 Participants
|
51 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
Clinical Characteristics of Study Subjects
History of Heart Failure
|
20 participants
n=5 Participants
|
25 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Clinical Characteristics of Study Subjects
New Diagnosis of Heart Failure
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Clinical Characteristics of Study Subjects
Diabetes mellitus
|
35 participants
n=5 Participants
|
46 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Clinical Characteristics of Study Subjects
History of Coronary Artery Disease
|
42 participants
n=5 Participants
|
35 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Clinical Characteristics of Study Subjects
Hypertension
|
74 participants
n=5 Participants
|
79 participants
n=7 Participants
|
153 participants
n=5 Participants
|
|
Clinical Characteristics of Study Subjects
Hyperlipidemia
|
53 participants
n=5 Participants
|
55 participants
n=7 Participants
|
108 participants
n=5 Participants
|
|
EKG on admission
normal sinus rhythm
|
81 participants
n=5 Participants
|
84 participants
n=7 Participants
|
165 participants
n=5 Participants
|
|
EKG on admission
Atrial fibrillation/flutter
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
EKG on admission
supraventricular tachycardia
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
EKG on admission
Other
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 minutesPopulation: There was only one patient in the Intervention group who received defibrillation. No patients had CPR or defibrillation in the standard of care group.
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.
Outcome measures
| Measure |
Experimental: AECD Monitoring + Stand of Care Group
n=95 Participants
Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
|
No Intervention: Standard of Care Group
n=97 Participants
Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
|
|---|---|---|
|
Number of Participants Without Defibrillation
|
94 participants
50
|
97 participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental: AECD Monitoring + Stand of Care Group
n=95 Participants
Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
|
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.
|
|---|---|---|
|
Frequency of Abnormal Rhythms Monitored by the AECD
Atrial Fibrillation/Flutter
|
9 participants
|
—
|
|
Frequency of Abnormal Rhythms Monitored by the AECD
Supraventricular Tachycardia
|
1 participants
|
—
|
|
Frequency of Abnormal Rhythms Monitored by the AECD
Premature Ventricular Complexes
|
10 participants
|
—
|
|
Frequency of Abnormal Rhythms Monitored by the AECD
Non-Sustained Ventricular Tachycardia
|
5 participants
|
—
|
SECONDARY outcome
Timeframe: At dischargeOutcome measures
| Measure |
Experimental: AECD Monitoring + Stand of Care Group
n=95 Participants
Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
|
No Intervention: Standard of Care Group
n=97 Participants
Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
|
|---|---|---|
|
Survival to Discharge
|
95 participants
|
97 participants
|
SECONDARY outcome
Timeframe: At dischargePopulation: Only 1 patient in the Intervention group had defibrillation during hospital admission and his CPC was 1.
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.
Outcome measures
| Measure |
Experimental: AECD Monitoring + Stand of Care Group
n=1 Participants
Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
|
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.
|
|---|---|---|
|
Cerebral Performance at Discharge
|
1 units on a scale: CPC 1
|
—
|
Adverse Events
Experimental: AECD Monitoring + Standard of Care Group
No Intervention: Standard of Care Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental: AECD Monitoring + Standard of Care Group
n=95 participants at risk
Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
|
No Intervention: Standard of Care Group
n=97 participants at risk
Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
|
|---|---|---|
|
Cardiac disorders
False Positive Events in which, the shocks were delivered inappropriately.
|
2.1%
2/95 • Number of events 2
|
0.00%
0/97
|
|
Cardiac disorders
Anxiety
|
2.1%
2/95 • Number of events 2
|
0.00%
0/97
|
|
Cardiac disorders
Skin irritation by the pads
|
2.1%
2/95 • Number of events 2
|
0.00%
0/97
|
|
Cardiac disorders
Alarming of the AECD, as the pads detached from the chest wall during sleep
|
4.2%
4/95 • Number of events 4
|
0.00%
0/97
|
Additional Information
Dr. A. Maziar Zafari
Atlanta Research and Education Foundation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place