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The aim of the study is to validate the Mean Arterial Pressure (MAP) parameter of Masimo INVSENSOR00073 against the gold standard blood pressure measurements from the arterial line while subject undergo a blood pressure variation procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Subject | Experimental | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00073 sensor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Masimo INVSENSOR00073 | Device | Noninvasive blood pressure monitor |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Pressure (MAP) Accuracy and Precision of Masimo INVSENSOR00073 | Accuracy and precision of mean arterial pressure (MAP) measured by Masimo INVSENSOR00073 in comparison to radial arterial line. | 1-5 hours. |
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Inclusion Criteria:
Influenced by study design:
Exclusion Criteria:
Influenced by device warning labels:
Influenced by study design/environment:
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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 INVSENSOR00073 | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00073 sensor. Masimo INVSENSOR00073: Noninvasive blood pressure monitor |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Subject | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00073 sensor. Masimo INVSENSOR00073: Noninvasive blood pressure monitor |
| 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 | Mean Arterial Pressure (MAP) Accuracy and Precision of Masimo INVSENSOR00073 | Accuracy and precision of mean arterial pressure (MAP) measured by Masimo INVSENSOR00073 in comparison to radial arterial line. | 9 subjects not analyzed due to incorrect software version | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | 1-5 hours. |
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1-5 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 INVSENSOR00073 | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00073 sensor. Masimo INVSENSOR00073: Noninvasive blood pressure monitor |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Venous sample complications | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Alghazi, M.B.Ch.B | Masimo Corporation | 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 | Jun 10, 2024 | Jun 19, 2025 | 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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| Participants |
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| 0 |
| 101 |
| 0 |
| 101 |
| 10 |
| 101 |
| Arterial line complications | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Infusion effects | Injury, poisoning and procedural complications | Non-systematic Assessment |
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