The Intrepid Clinical Engineering Study

Not Applicable

Completed

• Conditions: Sudden Cardiac Arrest
• Interventions: Diagnostic Test: 12 lead Electrocardiogram

• 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

Arm && Interventions

Group	Intervention	Description
24-hour opened electrodes	12 lead Electrocardiogram	Electrodes opened 24 hours
New electrodes	12 lead Electrocardiogram	New package of electrodes
30 day opened electrodes	12 lead Electrocardiogram	Electrodes opened 30 days

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

Trial Locations

Locations (1)

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