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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P170018 / PAS001 |
| Date Original Protocol Accepted |
12/21/2018
|
| Date Current Protocol Accepted |
|
| Study Name |
OUS Post Market Evaluation Study
|
| Device Name |
LIFEPAK® CR2 Defibrillator
|
| General Study Protocol Parameters |
| Study Design |
Active Surveillance
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Descriptive
|
| Study Population |
Adolescent: 13-18 yrs,
Transit.Adolescent A (distinctively):18 yrs<22 yrs,
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The objectives of the LIFEPAK CR2 defibrillator PAS are:
1. Characterize the performance of the cprINSIGHT algorithm
2. Identify any unanticipated use issues or performance concerns directly attributable to the cprINSIGHT algorithm
3. Evaluate general device usability data collected from LIFEPAK CR2 defibrillator users
|
| Study Population |
The study population is prehospital patients in Amsterdam, The Netherlands, who are presumed to be possible victims of cardiac arrest and who are connected to a LIFEPAK CR2 either at Schiphol International Airport, by Amsterdam Police, or by Amsterdam Fire.
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| Sample Size |
The minimum sample size is based on collecting at least 100 cases with coarse VF. It is estimated that about 20% of the cases will have at least one analysis of coarse VF, so the minimum sample size will be 500 patients. It is estimated that in approximately half of the cases with coarse VF, Analysis 1 by the SAS algorithm will reach a Shock Advised decision and there will be no VF after Shock 1, meaning that the cprINSIGHT algorithm will not see VF during the case. In the other approximately half of the cases, cprINSIGHT will analyze VF unless the patient is disconnected from the LIFEPAK CR2 defibrillator before an analysis of VF is completed. Therefore, it is expected that a minimum of 50 cases will have at least one analysis of VF by the cprINSIGHT algorithm.
The plan is to collect cases through the end of 2019 to comfortably exceed the above minimum sample sizes.
The plan is to collect device use survey forms for cases through the end of 2018.
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| Key Study Endpoints |
Study endpoints are accuracy of the LIFEPAK CR2 shock advisory decisions (made by the SAS algorithm or the cprINSIGHT algorithm), accuracy of just the SAS decisions, and accuracy of just the cprINSIGHT decisions, per the following table:
Rhythm Accuracy 90% Lower Confidence Limit
Shockable
Coarse VF Sensitivity
Rapid pulseless VT Sensitivity
Nonshockable
NSR Specificity
Other QRS rhythm Specificity
Asystole Specificity
Intermediate
Fine VF % shocked
Other VT % shocked
For the device use survey forms, the endpoint is a tabulation of survey answers.
|
| Follow-up Visits and Length of Follow-up |
no follow-up
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
790 cases ((33 airport cases, 555 police cases, 201 fire cases, and 1 case using a privately owned device)
|
| Actual Number of Sites Enrolled |
3
|
| Patient Follow-up Rate |
no follow-up, as the device recording and device use survey forms contain the data needed for the study.
|
| Final Safety Findings |
Overall sensitivity for shockable rhythms was 315/324 = 97.2% [90% LCL 95.6%]. Overall specificity was 1833/1856 = 98.8% [LCL 98.4%].
• The overall proportion of cprINSIGHT analyses that reached a decision with no Pause for SAS was 960/1360 = 70.7%. When the rhythm was coarse VF, 93.1% of cprINSIGHT analyses reached a decision with no Pause for SAS.
• No issues or performance concerns attributable to the cprINSIGHT algorithm were reported.
|
| Final Effect Findings |
Overall, the usuability gathered through LIFEPAK CR2 Use survey rate was 74%.
• In cases for which the voice prompts were reported to be annoying, distracting, or too verbose, there was no substantial adverse effect on the rescuers’ performance of the clinically important resuscitation tasks.
• The reported difficulty hearing the voice prompts or the metronome did not appear to adversely affect the rescuers’ performance of the clinically important resuscitation tasks, which are delivering CPR and delivering defibrillation shocks when needed.
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| Study Strengths & Weaknesses |
Study Strength include large sample size. There are no weaknesses.
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| Recommendations for Labeling Changes |
none
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