The Intrepid Clinical Engineering Study

NCT ID: NCT05636332

Last Updated: 2024-03-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-03

Study Completion Date

2022-11-02

Brief Summary

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

Detailed Description

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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.

Conditions

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Sudden Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors
The qualified electrocardiogram reviewer will be blinded to the age of electrodes

Study Groups

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New electrodes

New package of electrodes

Group Type OTHER

12 lead Electrocardiogram

Intervention Type DIAGNOSTIC_TEST

12 lead Electrocardiogram

24-hour opened electrodes

Electrodes opened 24 hours

Group Type OTHER

12 lead Electrocardiogram

Intervention Type DIAGNOSTIC_TEST

12 lead Electrocardiogram

30 day opened electrodes

Electrodes opened 30 days

Group Type OTHER

12 lead Electrocardiogram

Intervention Type DIAGNOSTIC_TEST

12 lead Electrocardiogram

Interventions

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12 lead Electrocardiogram

12 lead Electrocardiogram

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

29 Days

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Philips Clinical & Medical Affairs Global

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alaa El-Gendy, MD, MSc, FCCP

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Lehigh Acres, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CCTCECRIntrepid 12Lead2022

Identifier Type: -

Identifier Source: org_study_id

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