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This study is designed to evaluate the repeatability and reproducibility of ORi using an investigational Masimo rainbow sensor and FDA cleared rainbow sensors connected to the Masimo Radical-7 pulse oximeter and Masimo Root monitor in healthy volunteers as the subjects undergo a controlled hyperoxygenation protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Masimo Rainbow Sensors | Experimental | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo Rainbow Sensors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Masimo Rainbow Sensors | Device | Noninvasive pulse oximeter sensor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Repeatability of Masimo Rainbow Sensors | The Repeatability of ORi for Masimo Rainbow Sensors refers to the ability of a sensor to consistently produce the same readings under similar conditions (hyperoxia level).
| 1-1.5 hours |
| Reproducibility of Masimo Rainbow Sensors | The Reproducibility of ORi for Masimo Rainbow Sensors refers to the ability of two sensors to produce similar ORi results when measurements are taken under the same conditions (hyperoxia level).
| 1-1.5 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 Rainbow Sensors | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo Rainbow Sensors. Masimo Rainbow Sensors: Noninvasive pulse oximeter sensor |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Masimo Rainbow Sensors | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo Rainbow Sensors. Masimo Rainbow Sensors: Noninvasive pulse oximeter sensor |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Repeatability of Masimo Rainbow Sensors | The Repeatability of ORi for Masimo Rainbow Sensors refers to the ability of a sensor to consistently produce the same readings under similar conditions (hyperoxia level).
| 2 subjects not included in analysis for device setting errors. | Posted | Mean | Full Range | Mean Absolute Error (Unitless) | 1-1.5 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 Rainbow Sensors | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo Rainbow Sensors. Masimo Rainbow Sensors: Noninvasive pulse oximeter sensor |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Alghazi | 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 | Oct 3, 2022 | Apr 29, 2024 | Prot_SAP_000.pdf |
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| Participants |
|
| 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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| Primary | Reproducibility of Masimo Rainbow Sensors | The Reproducibility of ORi for Masimo Rainbow Sensors refers to the ability of two sensors to produce similar ORi results when measurements are taken under the same conditions (hyperoxia level).
| 5 subjects not included in analysis due to device setting errors. | Posted | Mean | Full Range | Mean Absolute Error (Unitless) | 1-1.5 hours |
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| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
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