The Intrepid Clinical Engineering Study

NCT05636332 | Completed Results FDA Device

• 1 other identifier: CCTCECRIntrepid 12Lead2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sudden Cardiac Arrest

Keywords

Monitor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Adverse Events

  day 1

• Unanticipated Adverse Device Effects (UADE)

  day 1

Study Arms (3)

New electrodes

OTHER

New package of electrodes

Diagnostic Test: 12 lead Electrocardiogram

24-hour opened electrodes

OTHER

Electrodes opened 24 hours

Diagnostic Test: 12 lead Electrocardiogram

30 day opened electrodes

OTHER

Electrodes opened 30 days

Diagnostic Test: 12 lead Electrocardiogram

Interventions

12 lead Electrocardiogram DIAGNOSTIC_TEST

12 lead Electrocardiogram

24-hour opened electrodes; 30 day opened electrodes; New electrodes

Eligibility Criteria

• Age: 29 Days - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates)

Lehigh Acres, Florida, 33971, United States

Location

MeSH Terms

Conditions

Death, Sudden, Cardiac

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Results Point of Contact

• Title: Tiffani Bowers
• Organization: Philips

tiffani.bowers@philips.com

724-989-3072

Study Officials

• Alaa El-Gendy, MD, MSc, FCCP

  Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The qualified electrocardiogram reviewer will be blinded to the age of electrodes
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: December 5, 2022
• Study Start: October 3, 2022
• Primary Completion: November 2, 2022
• Study Completion: November 2, 2022
• Last Updated: March 25, 2024
• Results First Posted: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)