Sudden Cardiac Arrest
Conditions
Keywords
Monitor
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.
Interventions
DIAGNOSTIC_TEST12 lead Electrocardiogram
12 lead Electrocardiogram
Sponsors
Heartstream US LLC
Philips Clinical & Medical Affairs Global
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
The qualified electrocardiogram reviewer will be blinded to the age of electrodes
Eligibility
Sex/Gender
ALL
Age
29 Days to 89 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validation of Algorithm Software Update | day 1 | Number of participants with failure to obtain a 12-lead Electrocardiogram (ECG) with the Philips HeartStart Intrepid Monitor/Defibrillator. |
| Diagnostic Quality | day 1 | Number of participants with diagnostic quality 12-lead ECG tracings from the Philips HeartStart Intrepid Monitor/Defibrillator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | day 1 | Participants with frequency and severity of unexpected adverse events |
| Unanticipated Adverse Device Effects (UADE) | day 1 | Participants with unanticipated adverse device effects (UADE). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlaa El-Gendy, MD, MSc, FCCP
Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| New Electrodes Unopened package of Electrodes will be applied to participants. | 20 |
| 24-hour Opened Electrodes Package of Electrodes will be opened 24- hour before applied to participants. | 20 |
| 30 Day Opened Electrodes Package of Electrodes will be opened 30 day (plus or minus 10 days) before applied to participants. | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Total | 30 Day Opened Electrodes | 24-hour Opened Electrodes | New Electrodes |
|---|---|---|---|---|
| Age, Continuous | 27.0 years STANDARD_DEVIATION 18.2 | 24.5 years STANDARD_DEVIATION 17 | 31.8 years STANDARD_DEVIATION 19.4 | 24.9 years STANDARD_DEVIATION 18.3 |
| Body Mass Index (BMI) | 27.9 kg/m^2 STANDARD_DEVIATION 8.8 | 29.0 kg/m^2 STANDARD_DEVIATION 11.1 | 29.4 kg/m^2 STANDARD_DEVIATION 8.2 | 25.4 kg/m^2 STANDARD_DEVIATION 6.1 |
| Erythema Index | 292.4 units on a scale STANDARD_DEVIATION 79.6 | 284.7 units on a scale STANDARD_DEVIATION 56 | 316.8 units on a scale STANDARD_DEVIATION 81.4 | 275.8 units on a scale STANDARD_DEVIATION 94.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants | 12 Participants | 14 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 8 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 58.8 inches STANDARD_DEVIATION 12 | 56.1 inches STANDARD_DEVIATION 12.1 | 61.6 inches STANDARD_DEVIATION 9.2 | 58.7 inches STANDARD_DEVIATION 14.3 |
| Melanin Index | 232.0 units on a scale STANDARD_DEVIATION 85.5 | 226.5 units on a scale STANDARD_DEVIATION 62.6 | 253.8 units on a scale STANDARD_DEVIATION 96.1 | 215.9 units on a scale STANDARD_DEVIATION 93.6 |
| Other observations: (Pallor, Jaundiced, Mottled, Cyanotic, etc.) | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Cuban | 9 Participants | 1 Participants | 5 Participants | 3 Participants |
| Race/Ethnicity, Customized Mexican | 15 Participants | 6 Participants | 0 Participants | 9 Participants |
| Race/Ethnicity, Customized Puerto Rican | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown or not reported | 2 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 32 Participants | 12 Participants | 13 Participants | 7 Participants |
| Region of Enrollment United States | 60 participants | 20 participants | 20 participants | 20 participants |
| Sex: Female, Male Female | 34 Participants | 12 Participants | 12 Participants | 10 Participants |
| Sex: Female, Male Male | 26 Participants | 8 Participants | 8 Participants | 10 Participants |
| Skin Moisture Dry | 60 Participants | 20 Participants | 20 Participants | 20 Participants |
| Skin Moisture Excessively Dry | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Skin Temperature Cold | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Skin Temperature Cool | 19 Participants | 7 Participants | 6 Participants | 6 Participants |
| Skin Temperature Hot | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Skin Temperature Warm-Normal | 41 Participants | 13 Participants | 14 Participants | 14 Participants |
| Skin Texture Firm | 3 Participants | 0 Participants | 2 Participants | 1 Participants |
| Skin Texture Rough | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Skin Texture Smooth | 54 Participants | 19 Participants | 17 Participants | 18 Participants |
| Skin Texture Soft | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Weight | 146.2 pounds STANDARD_DEVIATION 65.1 | 141.1 pounds STANDARD_DEVIATION 74.6 | 160.3 pounds STANDARD_DEVIATION 54.5 | 137.2 pounds STANDARD_DEVIATION 65.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Diagnostic Quality
Number of participants with diagnostic quality 12-lead ECG tracings from the Philips HeartStart Intrepid Monitor/Defibrillator.
Time frame: day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| New Electrodes | Diagnostic Quality | 20 Participants |
| 24-hour Opened Electrodes | Diagnostic Quality | 20 Participants |
| 30 Day Opened Electrodes | Diagnostic Quality | 20 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| New Electrodes | Validation of Algorithm Software Update | 0 Participants |
| 24-hour Opened Electrodes | Validation of Algorithm Software Update | 0 Participants |
| 30 Day Opened Electrodes | Validation of Algorithm Software Update | 0 Participants |
Secondary
Adverse Events
Participants with frequency and severity of unexpected adverse events
Time frame: day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| New Electrodes | Adverse Events | 0 Participants |
| 24-hour Opened Electrodes | Adverse Events | 0 Participants |
| 30 Day Opened Electrodes | Adverse Events | 0 Participants |
Secondary
Unanticipated Adverse Device Effects (UADE)
Participants with unanticipated adverse device effects (UADE).
Time frame: day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| New Electrodes | Unanticipated Adverse Device Effects (UADE) | 0 Participants |
| 24-hour Opened Electrodes | Unanticipated Adverse Device Effects (UADE) | 0 Participants |
| 30 Day Opened Electrodes | Unanticipated Adverse Device Effects (UADE) | 0 Participants |