The Intrepid Clinical Engineering Study
Study Details
Study Description
Brief Summary
The purpose of this research study is to collect clinical data to validate a software update for 12-lead electrocardiogram monitoring.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: New electrodes New package of electrodes |
Diagnostic Test: 12 lead Electrocardiogram
12 lead Electrocardiogram
|
Other: 24-hour opened electrodes Electrodes opened 24 hours |
Diagnostic Test: 12 lead Electrocardiogram
12 lead Electrocardiogram
|
Other: 30 day opened electrodes Electrodes opened 30 days |
Diagnostic Test: 12 lead Electrocardiogram
12 lead Electrocardiogram
|
Outcome Measures
Primary Outcome Measures
- Validation of algorithm software update [day 1]
Number of failures of unable to obtain a 12-lead Electrocardiogram (ECG) with the Philips HeartStart Intrepid Monitor/Defibrillator.
- Diagnostic quality [day 1]
Number of diagnostic quality 12-lead ECG tracings from the Philips HeartStart Intrepid Monitor/Defibrillator.
Secondary Outcome Measures
- Adverse Events [day 1]
Frequency and severity of unexpected adverse events
- Unanticipated adverse device effects (UADE) [day 1]
Unanticipated adverse device effects (UADE)
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Willing to have Philips representatives present during study procedures.
Exclusion Criteria:
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Known allergy to medical adhesives, silicone, or latex (per self-report)
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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)
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At the time of enrollment, current enrollment in any other interventional research study
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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)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates) | Lehigh Acres | Florida | United States | 33971 |
Sponsors and Collaborators
- Philips Clinical & Medical Affairs Global
Investigators
- Principal Investigator: Alaa El-Gendy, MD, MSc, FCCP, Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CCTCECRIntrepid 12Lead2022