The Intrepid Clinical Engineering Study

Sponsor
Philips Clinical & Medical Affairs Global (Industry)
Overall Status
Completed
CT.gov ID
NCT05636332
Collaborator
(none)
60
1
3
30
60.9

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
  • Diagnostic Test: 12 lead Electrocardiogram
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

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
The qualified electrocardiogram reviewer will be blinded to the age of electrodes
Primary Purpose:
Diagnostic
Official Title:
Philips HeartStart Intrepid 12-lead Electrocardiogram (ECG) Study - The ICE (Intrepid Clinical Engineering) Study
Actual Study Start Date :
Oct 3, 2022
Actual Primary Completion Date :
Nov 2, 2022
Actual Study Completion Date :
Nov 2, 2022

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

  1. 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.

  2. Diagnostic quality [day 1]

    Number of diagnostic quality 12-lead ECG tracings from the Philips HeartStart Intrepid Monitor/Defibrillator.

Secondary Outcome Measures

  1. Adverse Events [day 1]

    Frequency and severity of unexpected adverse events

  2. Unanticipated adverse device effects (UADE) [day 1]

    Unanticipated adverse device effects (UADE)

Eligibility Criteria

Criteria

Ages Eligible for Study:
29 Days to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

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.
Responsible Party:
Philips Clinical & Medical Affairs Global
ClinicalTrials.gov Identifier:
NCT05636332
Other Study ID Numbers:
  • CCTCECRIntrepid 12Lead2022
First Posted:
Dec 5, 2022
Last Update Posted:
Dec 5, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Philips Clinical & Medical Affairs Global
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 5, 2022