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This is a prospective, non-randomized data collection study to evaluate the form, fit, and function of INVSENSOR00061.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Masimo INVSENSOR00061 | Experimental | Experimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Masimo INVSENSOR00061 | Device | Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation ) |
|
| Measure | Description | Time Frame |
|---|---|---|
| SpO2 Accuracy of INVSENSOR00061 | SpO2 accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value which will be reported as percent of oxygen saturated hemoglobin. The noninvasive oxygen saturation measurement (SpO2) from the INVSENSOR00061 will be compared to the noninvasive oxygen saturation measurement (SpO2) value from the RD SET Neo sensor. | Approximately 15 minutes |
| Pulse Rate Accuracy of INVSENSOR00061 | Pulse Rate accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value through the comparison of the noninvasive Pulse Rate to the noninvasive Pulse Rate (PR) value obtained from the RD SET Neo sensor which will be reported as beats per minute. | Approximately 15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
• Subject has underdeveloped skin.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bailony Pediatrics | National City | California | 91950 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Masimo INVSENSOR00061 | Experimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained. Masimo INVSENSOR00061: Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation ) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Masimo INVSENSOR00061 | Experimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained. Masimo INVSENSOR00061: Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation ) |
| 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 | SpO2 Accuracy of INVSENSOR00061 | SpO2 accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value which will be reported as percent of oxygen saturated hemoglobin. The noninvasive oxygen saturation measurement (SpO2) from the INVSENSOR00061 will be compared to the noninvasive oxygen saturation measurement (SpO2) value from the RD SET Neo sensor. | 30 subjects were excluded from the analysis and replaced with new participants because of incorrect sensor placement. | Posted | Number | percent of oxygen saturated hemoglobin | Approximately 15 minutes |
|
Approximately 30 minutes
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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 INVSENSOR00061 | Experimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained. Masimo INVSENSOR00061: Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation ) |
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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 | May 2, 2023 | Apr 5, 2024 | Prot_SAP_000.pdf |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 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 | Pulse Rate Accuracy of INVSENSOR00061 | Pulse Rate accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value through the comparison of the noninvasive Pulse Rate to the noninvasive Pulse Rate (PR) value obtained from the RD SET Neo sensor which will be reported as beats per minute. | 30 subjects were excluded from the analysis and replaced with new participants because of incorrect sensor placement. | Posted | Number | beats per minute | Approximately 15 minutes |
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| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
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