Back to resultsThe Intrepid Clinical Engineering Study
Primary Purpose
Sudden Cardiac Arrest
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
12 lead Electrocardiogram
Sponsored by
About this trial
This is an interventional diagnostic trial for Sudden Cardiac Arrest focused on measuring Monitor
Eligibility Criteria
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)
Sites / Locations
- Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
New electrodes
24-hour opened electrodes
30 day opened electrodes
Arm Description
New package of electrodes
Electrodes opened 24 hours
Electrodes opened 30 days
Outcomes
Primary Outcome Measures
Validation of algorithm software update
Number of failures of unable to obtain a 12-lead Electrocardiogram (ECG) with the Philips HeartStart Intrepid Monitor/Defibrillator.
Diagnostic quality
Number of diagnostic quality 12-lead ECG tracings from the Philips HeartStart Intrepid Monitor/Defibrillator.
Secondary Outcome Measures
Adverse Events
Frequency and severity of unexpected adverse events
Unanticipated adverse device effects (UADE)
Unanticipated adverse device effects (UADE)
Full Information
NCT ID
NCT05636332
First Posted
November 10, 2022
Last Updated
December 1, 2022
Sponsor
Philips Clinical & Medical Affairs Global
1. Study Identification
Unique Protocol Identification Number
NCT05636332
Brief Title
The Intrepid Clinical Engineering Study
Official Title
Philips HeartStart Intrepid 12-lead Electrocardiogram (ECG) Study - The ICE (Intrepid Clinical Engineering) Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
November 2, 2022 (Actual)
Study Completion Date
November 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Clinical & Medical Affairs Global
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Cardiac Arrest
Keywords
Monitor
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The qualified electrocardiogram reviewer will be blinded to the age of electrodes
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
New electrodes
Arm Type
Other
Arm Description
New package of electrodes
Arm Title
24-hour opened electrodes
Arm Type
Other
Arm Description
Electrodes opened 24 hours
Arm Title
30 day opened electrodes
Arm Type
Other
Arm Description
Electrodes opened 30 days
Intervention Type
Diagnostic Test
Intervention Name(s)
12 lead Electrocardiogram
Intervention Description
12 lead Electrocardiogram
Primary Outcome Measure Information:
Title
Validation of algorithm software update
Description
Number of failures of unable to obtain a 12-lead Electrocardiogram (ECG) with the Philips HeartStart Intrepid Monitor/Defibrillator.
Time Frame
day 1
Title
Diagnostic quality
Description
Number of diagnostic quality 12-lead ECG tracings from the Philips HeartStart Intrepid Monitor/Defibrillator.
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Frequency and severity of unexpected adverse events
Time Frame
day 1
Title
Unanticipated adverse device effects (UADE)
Description
Unanticipated adverse device effects (UADE)
Time Frame
day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Days
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa El-Gendy, MD, MSc, FCCP
Organizational Affiliation
Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates)
City
Lehigh Acres
State/Province
Florida
ZIP/Postal Code
33971
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Intrepid Clinical Engineering Study
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