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This study is designed to compare the accuracy of a noninvasive measurement of heart rate compared to reference values obtained by a standard of care ECG monitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Masimo INVSENSOR00057 | Experimental | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00057 device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Masimo INVSENSOR00057 | Device | Noninvasive wearable health monitoring device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Accuracy of Masimo INVSENSOR00057 | Heart rate accuracy was determined by calculating the accuracy root mean-squared (Arms) difference between the measured values from Masimo INVSENSOR00057 (TestHR_i) to the reference ECG monitor values (RefHR_i). Arms= √(∑(i=1 to n) ((TestHR_i-RefHR_i )^2 ))/n | 1-3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masimo Corporation | Irvine | California | 92618 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Masimo INVSENSOR00057 | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00057 device. Masimo INVSENSOR00057: noninvasive wearable health monitoring device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Masimo INVSENSOR00057 | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00057 device. Masimo INVSENSOR00057: noninvasive wearable health monitoring device |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Heart Rate Accuracy of Masimo INVSENSOR00057 | Heart rate accuracy was determined by calculating the accuracy root mean-squared (Arms) difference between the measured values from Masimo INVSENSOR00057 (TestHR_i) to the reference ECG monitor values (RefHR_i). Arms= √(∑(i=1 to n) ((TestHR_i-RefHR_i )^2 ))/n | 17 subjects not included in analysis due to data collection error. | Posted | Number | bpm | 1-3 hours |
|
1-3 hours
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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 | Masimo INVSENSOR00057 | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00057 device. Masimo INVSENSOR00057: noninvasive wearable health monitoring device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Alghazi | Masimo | 949-297-7000 | studies@masimo.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 | Apr 4, 2022 | Apr 29, 2024 | Prot_SAP_000.pdf |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 86 |
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| 86 |
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| 86 |
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