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Assess the accuracy of INVSENSOR00069's peripheral oxygen saturation (SpO2) against contemporaneous measurement from arterial blood gas (ABG) analysis.
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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 have the Masimo INVSENSOR00069. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVSENSOR00069 | Device | Noninvasive pulse oximeter |
|
| Measure | Description | Time Frame |
|---|---|---|
| SpO2 Accuracy of Masimo INVSENSOR00069 | The SpO2 accuracy of Masimo INVSENSOR00069 was determined by calculating the accuracy root mean-squared (Arms) difference between the measured values (SpO2) to the reference values (SaO2) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2_i-SaO2_i )^2 ))/n. | 1-3 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 INVSENSOR00069 | All subjects who are enrolled into the test group and participate in data collection have the Masimo INVSENSOR00069. INVSENSOR00069: Noninvasive pulse oximeter |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Masimo INVSENSOR00069 | All subjects who are enrolled into the test group and participate in data collection have the Masimo INVSENSOR00069. INVSENSOR00069: Noninvasive pulse oximeter |
| 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 Masimo INVSENSOR00069 | The SpO2 accuracy of Masimo INVSENSOR00069 was determined by calculating the accuracy root mean-squared (Arms) difference between the measured values (SpO2) to the reference values (SaO2) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2_i-SaO2_i )^2 ))/n. | 10 subjects not analyzed due to incorrect sensor 3 subjects not analyzed due to not desaturating to the lowest bin (70-80%) | Posted | Number | % of oxygen saturated hemoglobin | 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 INVSENSOR00069 | All subjects who are enrolled into the test group and participate in data collection have the Masimo INVSENSOR00069. INVSENSOR00069: Noninvasive pulse oximeter |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness/Lightheadedness | Nervous system disorders | Systematic Assessment |
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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 | Aug 23, 2023 | Sep 23, 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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| Units | Counts |
|---|
| Participants |
|
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| 0 |
| 86 |
| 0 |
| 86 |
| 9 |
| 86 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Increased heart rate | Cardiac disorders | Systematic Assessment |
|
| Numbness | Nervous system disorders | Systematic Assessment |
|
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