The Intrepid Clinical Engineering Study

Philips Clinical & Medical Affairs Global60 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Sudden Cardiac Arrest

Interventions

12 lead ElectrocardiogramDIAGNOSTIC_TEST

12 lead Electrocardiogram

Eligibility

Sex: ALLMin age: 29 DaysMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

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

Lehigh Acres, Florida, United States

Outcomes

Primary Outcomes

Validation of Algorithm Software Update

Number of participants with failure to obtain a 12-lead Electrocardiogram (ECG) with the Philips HeartStart Intrepid Monitor/Defibrillator.

Time frame: day 1

Diagnostic Quality

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

Time frame: day 1

Secondary Outcomes

Adverse Events

Participants with frequency and severity of unexpected adverse events

Time frame: day 1

Unanticipated Adverse Device Effects (UADE)

Participants with unanticipated adverse device effects (UADE).

Time frame: day 1

Data from ClinicalTrials.gov

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