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This is a prospective, nonrandomized multi-center study for the investigation of noninvasive sphygmomanometers.
The purpose of the study is to validate the clinical performance of the Masimo noninvasive blood pressure device compared to reference auscultatory measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test subjects | Experimental | All subjects enrolled had blood pressure measurements taken using the noninvasive blood pressure device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Masimo Noninvasive Blood Pressure Device | Device | Non-invasive blood pressure device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean and Standard Deviation of Differences Between Masimo NIBP Device and Manual Sphygmomanometer Measurements. | Performance will be determined by calculating the mean and standard deviation of the differences between the systolic and diastolic blood pressure measurements obtained from Masimo NIBP device and manual sphygmomanometer. | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 2 | Irvine | California | 92618 | United States | ||
| Site 1 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Subjects | Masimo Noninvasive Blood Pressure Device: All enrolled subjects will have blood pressure measurements done using the Masimo NIBP device and the noninvasive blood pressure device |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Subjects | Masimo Noninvasive Blood Pressure Device: All enrolled subjects will have blood pressure measurements done using the Masimo NIBP device and the noninvasive blood pressure device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Mean and Standard Deviation of Differences Between Masimo NIBP Device and Manual Sphygmomanometer Measurements. | Performance will be determined by calculating the mean and standard deviation of the differences between the systolic and diastolic blood pressure measurements obtained from Masimo NIBP device and manual sphygmomanometer. | Subjects excluded from analysis were as follows:
| Posted | Mean | Standard Deviation | mmHg | 1 hour |
|
1 hour
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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 | Test Subjects | All subjects enrolled had blood pressure measurements taken using the noninvasive blood pressure device. Masimo Noninvasive Blood Pressure Device: Non-invasive blood pressure device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Frank | Masimo Corporation | 949-297-7000 | clinicalresearchdept@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 | Oct 3, 2020 | Jun 29, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Lomita |
| California |
| 90717 |
| United States |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
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| 0 |
| 106 |
| 0 |
| 106 |
| 0 |
| 106 |
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