An interventional study of STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS in Healthy and Hypoxia, sponsored by Stryker Sustainability Solutions. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-20.
Sponsored by Stryker Sustainability Solutions · Not applicable, Interventional, and Other
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 3 levels, e.g. 95%, 85%, and 75% saturation for about 30-60 seconds at each level), thereby demonstrating an acceptable SpO2 accuracy performance specification.
1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.
This study's enrollment of 12 is below the median of 45 across 853 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →Stryker Sustainability Solutions is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors.
Device: STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS
Reprocessed noninvasive pulse oximeter sensors.
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.
Time frame: 1-2 hours
| Milestone | Healthy Adult Participants |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
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.
| Root Mean Square Error (%) | Device 1: Reprocessed Masimo RD Set Pulse Oximeter Sensor, 4000 Adt | Device 2: Reprocessed Masimo RD Set Pulse Oximeter Sensor, 4003 Neo |
|---|---|---|
| Accuracy of Sensor by Arms Calculation | 2.04 | 2.11 |
Collected over 2 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Device 1 | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Device 2 | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | Healthy Adult Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Healthy Adult Participants |
|---|---|
| Female | 7 |
| Male | 5 |
| Race/Ethnicity, Customized(Participants) | Healthy Adult Participants |
|---|---|
| Caucasian | 2 |
| Black or African American | 3 |
| Asian | 4 |
| Hispanic | 1 |
| Multiethnic | 2 |
| Region of Enrollment(participants) | Healthy Adult Participants |
|---|---|
| United States | 12 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Data to be used by Sponsor only.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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