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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors.
In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the participant breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.
It is required that the Accuracy Root Mean Square (ARMS) performance of the Stryker pulse oximetry sensors will meet a specification of +/-3% or better in motion conditions for the range of 70 - 100% SaO2 (typically, saturation is determined once with air breathing and then at one of 6 levels, e.g. 94%, 90%, 85%, 80%, 75% and 70% saturation for about 30-60 seconds at each level), thereby demonstrating an acceptable SpO2 accuracy performance specification. Motion is defined as controlled rubbing or tapping of the subject's fingers in a 2-4 Hz or random sine motion with 2-3 cm amplitude.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy adult participants | Experimental | All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS | Device | Reprocessed noninvasive pulse oximeter sensors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Sensor by Arms Calculation Under Motion Conditions | Percentage of SpO2 (oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. Accuracy root mean square (ARMS) between measured SpO2 and reference SaO2 (arterial oxygen saturation) must meet the 3% specification for each reprocessed pulse oximetry sensor style. 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. Standard deviation of the differences is computed as the precision. Square root of the sum of the squares of bias and precision is computed as the Arms Error value. | 1-2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip E Bickler, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Hypoxia Research Laboratory | San Francisco | California | 94133 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Adult Participants | All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors. STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS: Reprocessed noninvasive pulse oximeter sensors. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Adult Participants | All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors. STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS: Reprocessed noninvasive pulse oximeter sensors. |
| 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 | Accuracy of Sensor by Arms Calculation Under Motion Conditions | Percentage of SpO2 (oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. Accuracy root mean square (ARMS) between measured SpO2 and reference SaO2 (arterial oxygen saturation) must meet the 3% specification for each reprocessed pulse oximetry sensor style. 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. Standard deviation of the differences is computed as the precision. Square root of the sum of the squares of bias and precision is computed as the Arms Error value. | Posted | Number | Root Mean Square Error (%) | 1-2 hours |
|
2 days
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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 | Device 1 | All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors. STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS: Reprocessed noninvasive pulse oximeter sensors. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Monique Ketcher | Stryker Sustainability Solutions | 602-354-0917 | monique.ketcher@stryker.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 1, 2022 | Feb 6, 2023 | Prot_SAP_000.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 |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors. Device 1 consists of non-woven butterfly style tape.
STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS: Reprocessed noninvasive pulse oximeter sensors.
| OG001 | Device 2 | All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors. Device 2 consists of a woven style tape. STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS: Reprocessed noninvasive pulse oximeter sensors. |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Device 2 | All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors. STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS: Reprocessed noninvasive pulse oximeter sensors. | 0 | 12 | 0 | 12 | 0 | 12 |
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