The Intrepid Clinical Engineering Study

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

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

Study Overview

• Status: Completed
• Conditions: Sudden Cardiac Arrest
• Intervention / Treatment: Diagnostic test: 12 lead Electrocardiogram

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Lehigh Acres, Florida, United States, 33971
      • Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 87 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of Algorithm Software Update	Number of participants with failure to obtain a 12-lead Electrocardiogram (ECG) with the Philips HeartStart Intrepid Monitor/Defibrillator.	day 1
Diagnostic Quality	Number of participants with 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	Participants with frequency and severity of unexpected adverse events	day 1
Unanticipated Adverse Device Effects (UADE)	Participants with unanticipated adverse device effects (UADE).	day 1

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): October 3, 2022
• Primary Completion (Actual): November 2, 2022
• Study Completion (Actual): November 2, 2022

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Monitor
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Heart Arrest; Death, Sudden, Cardiac
• Other Study ID Numbers: CCTCECRIntrepid 12Lead2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No