The Intrepid Clinical Engineering Study

Study Overview
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Brief Summary
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The purpose of this research study is to collect clinical data to validate a software update for 12-lead electrocardiogram monitoring.

Detailed Description
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The purpose of this study is to validate the Philips DXL electrocardiogram Algorithm works as intended in the HeartStart Intrepid Monitor/Defibrillator after a software update was completed to address instances of high impedance. This study will also determine the diagnostic quality of the 12-lead electrocardiogram tracing from the HeartStart Intrepid Monitor/Defibrillator.

Official Title
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Philips HeartStart Intrepid 12-lead Electrocardiogram (ECG) Study - The ICE (Intrepid Clinical Engineering) Study

Conditions
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Sudden Cardiac Arrest

Intervention / Treatment
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* Diagnostic Test: 12 lead Electrocardiogram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to read, write, speak, and understand English Age: 29 days to 89 years Willing and able to provide informed consent and complete study procedures Willing to have Philips representatives present during study procedures. Exclusion Criteria: Known allergy to medical adhesives, silicone, or latex (per self-report) Any limitation or medical condition, including but not limited to physical or cognitive disability, that would affect the participant's ability to complete study activities (per investigator) At the time of enrollment, current enrollment in any other interventional research study An employee, or residing family member of an employee, of a company that designs, sells, or manufactures monitor/defibrillator technology or related products (including Philips)

Ages Eligible for Study
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Minimum Age: 29 Days
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: New electrodes<br>New package of electrodes | Diagnostic Test: 12 lead Electrocardiogram<br>* 12 lead Electrocardiogram<br>|
| Other: 24-hour opened electrodes<br>Electrodes opened 24 hours | Diagnostic Test: 12 lead Electrocardiogram<br>* 12 lead Electrocardiogram<br>|
| Other: 30 day opened electrodes<br>Electrodes opened 30 days | Diagnostic Test: 12 lead Electrocardiogram<br>* 12 lead Electrocardiogram<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of algorithm software update | Number of failures of unable to obtain a 12-lead Electrocardiogram (ECG) with the Philips HeartStart Intrepid Monitor/Defibrillator. | day 1 | 
| Diagnostic quality | Number of diagnostic quality 12-lead ECG tracings from the Philips HeartStart Intrepid Monitor/Defibrillator. | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Frequency and severity of unexpected adverse events | day 1 | 
| Unanticipated adverse device effects (UADE) | Unanticipated adverse device effects (UADE) | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Monitor