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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest.
This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult healthy subjects | Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse oximeter | Device | OLV-4202 pulse oximeter (SW version: 01-11) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Sensor Oxygen Saturation by Arms Calculation | Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter (SpO2i) to that obtained from a blood sample (SRi) and calculating the arithmetic root mean square (Arms) error value as follows: Arms =Square root (sum of n samples of ((SpO2i - SRi) squared) / n) | 30 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Sensor Pulse Rate by Arms Calculation | Accuracy will be determined by comparing the noninvasive pulse rate measurement of the pulse oximeter (PRi) to the heart rate obtained from an electrocardiography reference device (HRRi) and calculating the arithmetic root mean square (Arms) error value as follows: Arms =Square root (sum of n samples of ((PRi - HRRi) squared) / n) | 30 seconds |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy adult volunteers. At least 10 subjects will be recruited to complete the study. Of these 2 will be dark pigmented. If the number of samples is less than the required 200 or if less than 2 of dark pigment subjects successfully complete the study, subjects will be added to include 2 of dark pigmented subjects and at least 200 data points.
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| Name | Affiliation | Role |
|---|---|---|
| Philip Bickler, MD, PhD | UCSF Hypoxia Research Laboratory | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Hypoxia Research Laboratory | San Francisco | California | 94133 | United States |
Data to be used by Sponsor only
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| ID | Title | Description |
|---|---|---|
| FG000 | Adult Healthy Subjects | Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state Pulse oximeter: OLV-4202 pulse oximeter (SW version: 01-11) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Adult Healthy Subjects | Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state Pulse oximeter: OLV-4202 pulse oximeter (SW version: 01-11) |
| 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 | Accuracy of Sensor Oxygen Saturation by Arms Calculation | Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter (SpO2i) to that obtained from a blood sample (SRi) and calculating the arithmetic root mean square (Arms) error value as follows: Arms =Square root (sum of n samples of ((SpO2i - SRi) squared) / n) | Qualified subjects with valid arterial line. | Posted | Number | percentage of RMS error | 30 seconds |
|
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 | Adult Healthy Subjects | Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state Pulse oximeter: OLV-4202 pulse oximeter (SW version: 01-11) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Philip Bickler | UCSF Hypoxia Research Laboratory | 1-415-476-1411 | philip.bickler@ucsf.edu |
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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 1, 2025 | Sep 1, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 | Number | participants |
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| Units | Counts |
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| Participants |
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| Secondary | Accuracy of Sensor Pulse Rate by Arms Calculation | Accuracy will be determined by comparing the noninvasive pulse rate measurement of the pulse oximeter (PRi) to the heart rate obtained from an electrocardiography reference device (HRRi) and calculating the arithmetic root mean square (Arms) error value as follows: Arms =Square root (sum of n samples of ((PRi - HRRi) squared) / n) | Qualified subjects with valid arterial line. | Posted | Number | percentage of RMS error | 30 seconds |
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| 0 |
| 13 |
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| 13 |
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