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In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor under motion conditions will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RD Disposable Sensors | Experimental | All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RD Disposable Sensors | Device | Noninvasive pulse oximeter sensor |
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| Measure | Description | Time Frame |
|---|---|---|
| SpO2 ARMS of Sensor Under Motion Conditions | Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value. | 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 | RD Disposable Sensors | All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | RD Disposable Sensors | All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors RD Disposable Sensors: 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, 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 ARMS of Sensor Under Motion Conditions | Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value. | 2 subjects were excluded from data analysis: one due to adverse event and the other due to equipment malfunction. | Posted | Number | % of oxygen saturated hemoglobin | 1-5 hours |
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Adverse event data was collected over the course of the study (within 1 month).
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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 | RD Disposable Sensors | All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sensitivity at site of arterial line placement | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tala Harake | 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 | Sep 22, 2015 | Jan 19, 2018 | 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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| Region of Enrollment | Count of Participants | Participants |
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| 0 |
| 27 |
| 0 |
| 27 |
| 2 |
| 27 |
| Irregular heart rate | General disorders | Non-systematic Assessment |
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