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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P160022 / PAS001 |
| Date Original Protocol Accepted |
12/27/2017
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| Date Current Protocol Accepted |
05/19/2021
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| Study Name |
Reconfirmation Analysis Mode Algorithm PAS
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| Device Name |
X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™ Battery Pack, SurePower II™ Battery Pack, AED Pro® Non-Rechargeable Lithium Battery Pack, AED 3™ Battery Pack, SurePower™ Charger, and SurePower™ Single Bay Charger
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Study Population |
Neonate: 1-28 days,
Infant: 29 days-2 yrs,
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective observational study with newly enrolled patients. Enrollment for this study is approximately 70 months. Subjects are enrolled once the Zoll X Series, R series, AED Pro, or Zoll AED 3 is connected to the patient via electrodes and ECG data capture begins. Data collection will contine to through the duration of the resuscitation event while the ECG capture is in place.
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| Study Population |
Subjects are enrolled in this study when they are found in cardiac arrest and receive attempted resuscitation by participating EMS agencies and treatment with the ZOLL X-Series defibrillator. Subjects meeting the labeled indications for use will be recruited into the study with the following inclusion and exclusion criteria based on the current labeling for X-Series.
Inclusion Criteria:
Candidates for this study must meet all of the following criteria:
1. Age greater than or equal to 8 years and weight greater than or equal to 55 pounds (25 kg)
2. Out-of-hospital cardiac arrest (OOHCA)
3. Non-traumatic arrest
Exclusion Criteria:
Candidates will be excluded from the study if any of the
following conditions are present:
1. Weight less than 55 pounds (25 kg)
2. Do-not-attempt-resuscitation (DNAR) orders.
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| Sample Size |
Approximately 2500 subjects are planned to be enrolled in the study to provide adequate data for all rhythms in the final analysis. Currently, the rate limiting rhythm is anticipated to be Rapid VT as it quickly degrades to VF and is rare to capture in waveform data. Historically, only 2% of all rhythms assessed in previous datasets were categorized as rapid VT. To satisfy the minimum of 50 subjects for rapid VT, 2500 subjects will be enrolled.
Based on Kerber’s sample size and performance goals listed in the Kerber et al. 1997 article referred above, the following minimum sample sizes for five different categories of rhythm will be required for this study.
For Coarse VF,
When the sample size is 200, a one-sided 90.0% confidence interval for a single proportion using the large sample normal approximation will extend 0.027 from the observed proportion for an expected proportion of 0.900.
For Rapid VT
When the sample size is 50, a one-sided 90.0% confidence interval for a single proportion using the large sample normal approximation will extend 0.078 from the observed proportion for an expected proportion of 0.750.
For Non-Shockable Rhythm
When the sample size is 100, a one-sided 90.0% confidence interval for a single proportion using the large sample normal approximation will extend 0.013 from the observed proportion for an expected proportion of 0.990.
For Other Non-Shockable Rhythms (AF, SB, SVT, PVCs)
When the sample size is 30, a one-sided 90.0% confidence interval for a single proportion using the large sample normal approximation will extend 0.051 from the observed proportion for an expected proportion of 0.950.
For Asystole
When the sample size is 100, a one-sided 90.0% confidence interval for a single proportion using the large sample normal approximation will extend 0.028 from the observed proportion for an expected proportion of 0.950.
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| Key Study Endpoints |
The primary endpoint is the accuracy of the RAM algorithm (i.e., measured as sensitivity for shockable rhythms and specificity for non-shockable rhythms for the algorithm) compared to manual annotation for each rhythm type.
Primary outcome measure:
ECG data files will be manually annotated as shockable or non-shockable by two (2) non-physician experts in ECG cardiac rhythm analysis and one (1) physician expert in ECG analysis. This annotation will be based on the ECG waveform immediately following the end of the CPR compression interval only; that is, the annotation will be done only with the portion of the ECG waveform that is free from CPR artifact. The shock determination decision reached by the cardiac monitor will be compared with the manual annotations of the same ECG data by the three (3) experts.
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| Follow-up Visits and Length of Follow-up |
No follow-up visits
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| Interim or Final Data Summary |
| Interim Results |
There have been no reports of unanticipated adverse events in the study.
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| Actual Number of Patients Enrolled |
1542
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| Actual Number of Sites Enrolled |
5
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| Patient Follow-up Rate |
ECG segments have been annotated for 770 participants and they accounted for 4431 rhythm analyses where RapidShock was deployed. 317/4431 segments were determined to have a noisy ECG signal due to compression interference or artifact occurring while the algorithm was attempting analysis; 41 of the noisy segments were determined by the algorithm to be shockable while 276 were determined to be non-shockable
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| Study Strengths & Weaknesses |
The sponsor is intending to enroll more patients within the clinical sites
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