Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
Not provided
Not provided
Not provided
The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during non-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 non-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.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 oximeters
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Sensor by Arms Calculation | Percentage of SpO2 (oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during non-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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Data to be used by Sponsor only
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 oximeters
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 oximeters
|
| 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 | Percentage of SpO2 (oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during non-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
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 oximeters
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Monique Ketcher | Stryker Sustainability Solutions | 602-354-0917 | monique.ketcher@stryker.com |
Not provided
| 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 | Nov 2, 2021 | Nov 29, 2022 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Participants will be in a reclined position for the study. Reference sensors will be placed on each participant to evaluate the SpO2 accuracy and performance. Sensors may be placed on non-adjacent fingers to prevent optical crosstalk. Simultaneous data collection will be set up for devices under test. The data from the test devices will be collected by the sponsor or trained UCSF staff. Data will be collected for 1-2 second intervals data analysis. The SpO2 accuracy of the test devices will be evaluated over the oxygen saturation range between 70-100%.
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Reprocessed MAX-A | All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors. |
| OG002 | Reprocessed 1859 | All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors. |
| OG003 | Reprocessed 2329 | All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors. |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
Not provided
Not provided