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This study is designed to measure the trending accuracy of a noninvasive regional oximetry measurement of somatic oxygen saturation. Two large sensors (adult sensors) will be placed on the subject's forehead. Two investigational sensors (INVSENSOR00028) will be placed on the forearm of the volunteer. The values obtained by the INVSENSOR00028 will be compared to the reference value calculated from the arterial and venous blood measurements. Data will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen saturation is approximately 70%, while blood samples are drawn at prespecified reference points. The subject will then be returned to inhaling room air.
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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 INVSENSOR00028 sensor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVSENSOR00028 | Device | Noninvasive pulse oximeter sensor |
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| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Saturation (rSO2) Accuracy of Sensor | The Trending accuracy of the INVSENSOR00028 will be evaluated relative to the reference value calculated from the arterial and venous blood measurements. | 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 |
Of the 46 enrolled participants, 23 met inclusion criteria and proceeded to the study. The remainder of the enrolled participants include screen failures and subjects that did not proceed due to time constraints.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Subject | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00028 sensor. INVSENSOR00028: Noninvasive pulse oximeter sensor |
| 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 INVSENSOR00028 sensor. INVSENSOR00028: Noninvasive pulse oximeter sensor |
| 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, 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 | Oxygen Saturation (rSO2) Accuracy of Sensor | The Trending accuracy of the INVSENSOR00028 will be evaluated relative to the reference value calculated from the arterial and venous blood measurements. | There is no apparent trend in either the Brachial or Flexor RSO2 data with respect to the control. Since there is no measurable trend, a numerical value for Trending Accuracy (as defined in the protocol) cannot be accurately determined. | Posted | 1-5 hours |
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1 to 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 | Test Subject | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00028 sensor. INVSENSOR00028: Noninvasive pulse oximeter sensor |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Frank | 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 | Feb 26, 2019 | Jun 24, 2021 | 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/Ethnicity, Customized | Count of Participants | Participants |
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| Units |
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| Counts |
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| Participants |
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| 0 |
| 20 |
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| 20 |
| 3 |
| 20 |
| Sensitivity at arterial line site | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Lightheadedness | Injury, poisoning and procedural complications | Non-systematic Assessment |
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