The Intrepid Clinical Engineering Study

Not Applicable

Completed

• Conditions: Sudden Cardiac Arrest

• Registration Number: NCT05636332
• Lead Sponsor: Philips Clinical & Medical Affairs Global

Brief Summary

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

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 Timeline

• Study Start: 2022-10-03
• Primary Completion: 2022-11-02
• Study Completion: 2022-11-02
• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-05
• Results First Submitted: 2023-10-26
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-22
• Last Update Submitted: 2024-03-22
• Results First Posted: 2024-03-25
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Validation of Algorithm Software Update	day 1	Number of participants with failure to obtain a 12-lead Electrocardiogram (ECG) with the Philips HeartStart Intrepid Monitor/Defibrillator.
Diagnostic Quality	day 1	Number of participants with diagnostic quality 12-lead ECG tracings from the Philips HeartStart Intrepid Monitor/Defibrillator.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	day 1	Participants with frequency and severity of unexpected adverse events
Unanticipated Adverse Device Effects (UADE)	day 1	Participants with unanticipated adverse device effects (UADE).

Trial Locations

Locations (1)

Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates); 🇺🇸 Lehigh Acres, Florida, United States