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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New electrodes | Other | New package of electrodes |
|
| 24-hour opened electrodes | Other | Electrodes opened 24 hours |
|
| 30 day opened electrodes | Other | Electrodes opened 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12 lead Electrocardiogram | Diagnostic Test | 12 lead Electrocardiogram |
|
| Measure | Description | Time Frame |
|---|---|---|
| Validation of Algorithm Software Update | Number of participants with failure to obtain a 12-lead Electrocardiogram (ECG) with the Philips HeartStart Intrepid Monitor/Defibrillator. | day 1 |
| Diagnostic Quality | Number of participants with diagnostic quality 12-lead ECG tracings from the Philips HeartStart Intrepid Monitor/Defibrillator. | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Participants with frequency and severity of unexpected adverse events | day 1 |
| Unanticipated Adverse Device Effects (UADE) | Participants with unanticipated adverse device effects (UADE). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alaa El-Gendy, MD, MSc, FCCP | Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates) | Lehigh Acres | Florida | 33971 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | New Electrodes | Unopened package of Electrodes will be applied to participants. |
| FG001 | 24-hour Opened Electrodes | Package of Electrodes will be opened 24- hour before applied to participants. |
| FG002 | 30 Day Opened Electrodes. | Package of Electrodes will be opened 30 day (plus or minus 10 days) before applied to participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | New Electrodes | Unopened package of Electrodes will be applied to participants. |
| BG001 | 24-hour Opened Electrodes | Package of Electrodes will be opened 24- hour before applied to participants. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | day 1 |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | New Electrodes | Unopened package of Electrodes will be applied to participants. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tiffani Bowers | Philips | 724-989-3072 | tiffani.bowers@philips.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 12, 2022 | Oct 26, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
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| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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The qualified electrocardiogram reviewer will be blinded to the age of electrodes
| day 1 |
| BG002 | 30 Day Opened Electrodes | Package of Electrodes will be opened 30 day (plus or minus 10 days) before applied to participants. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | pounds |
|
| Height | Mean | Standard Deviation | inches |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Melanin Index | Melanin index is optical skin parameter related to the melanin content in the tissue. Results are on a broad scale from 0 to 999 over 1 second to detect even the tiniest melanin/redness changes. This measurement is not intended to represent a more favorable tissue condition over other participants in the cohort. The higher the index number, the more pigment is present in the tissue. | Mean | Standard Deviation | units on a scale |
|
| Erythema Index | Erythema Index is optical skin parameter related to the redness content in the tissue. Results are on a broad scale from 0 to 999 over 1 second to detect even the tiniest redness changes. This measurement is not intended to represent a more favorable tissue condition over other participants in the cohort. The higher the index number, the more pigment is present in the tissue. | Mean | Standard Deviation | units on a scale |
|
| Skin Temperature | Count of Participants | Participants |
|
| Skin Moisture | Count of Participants | Participants |
|
| Skin Texture | Count of Participants | Participants |
|
| Other observations: (Pallor, Jaundiced, Mottled, Cyanotic, etc.) | This measurement was documented as open text for the study team to add any additional skin conditions that were outside of the already described parameters. | Count of Participants | Participants |
|
Package of Electrodes will be opened 30 day (plus or minus 10 days) before applied to participants.
|
|
| Primary | Diagnostic Quality | Number of participants with diagnostic quality 12-lead ECG tracings from the Philips HeartStart Intrepid Monitor/Defibrillator. | Posted | Count of Participants | Participants | day 1 |
|
|
|
| Secondary | Adverse Events | Participants with frequency and severity of unexpected adverse events | Posted | Count of Participants | Participants | day 1 |
|
|
|
| Secondary | Unanticipated Adverse Device Effects (UADE) | Participants with unanticipated adverse device effects (UADE). | Posted | Count of Participants | Participants | day 1 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 24-hour Opened Electrodes | Package of Electrodes will be opened 24- hour before applied to participants. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | 30 Day Opened Electrodes | Package of Electrodes will be opened 30 day (plus or minus 10 days) before applied to participants. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004568 | Electrodiagnosis |