An interventional study of Experimental Masimo RD SET SpO2 Adhesive Sensors in Healthy and Hypoxia, sponsored by Stryker Sustainability Solutions. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-06.
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 motion conditions over the range of 70 -100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry during conditions in which the subject is moving. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors with motion indications.
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 will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.
A machine will be used to induce motions of 20 mm during testing at a sine rate of 2Hz, 3Hz, and 4Hz. A third motion moves the arm a random distance of 0 to 30mm at a random speed up to 5Hz.
It is required that the Accuracy Root Mean Square (ARMS) performance of the Stryker pulse oximetry sensors will meet a specification of +/-3% with a target 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 three or six levels, e.g. 94%, 90%, 85%, 80%, 75% and 70% or 95%, 85% and 75% saturation for about 30-60 seconds or 60-90 seconds at each level), thereby demonstrating an acceptable SpO2 accuracy performance specification. This study should utilize a three level structure (95%, 85% and 75%).
1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.
This study's enrollment of 11 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:
The subject is obese (BMI>30)
Experimental: Healthy adult participants All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors
Device: Experimental Masimo RD SET SpO2 Adhesive Sensors
Masimo RD SET SpO2 Adhesive Sensors, Adult (4000 Adt), Adult \& Neonate (4003 Neo)
Accuracy of Sensor by Comparing SpO2 Percent Blood Oxygen Saturation to SaO2 Percent Blood Oxygen Saturation Utilizing Arms Calculation Calculation [Time Frame: 1 - 5 Hours]
The outcome of this study is the accuracy of the SpO2 (percent oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during motion conditions over the range of 70 - 100% saturation compared to SaO2 (percent oxygen saturation by co-oximetry from blood samples) from arterial blood samples. The accuracy is calculated using the Arms error between measured SpO2 and reference SaO2. The Arms must meet the 3% specification for each reprocessed pulse oximetry sensor style. 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 - 5 hours
| Milestone | Healthy Adult Participants |
|---|---|
| Started | 11 |
| Completed | 11 |
| Not completed | 0 |
The outcome of this study is the accuracy of the SpO2 (percent oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during motion conditions over the range of 70 - 100% saturation compared to SaO2 (percent oxygen saturation by co-oximetry from blood samples) from arterial blood samples. The accuracy is calculated using the Arms error between measured SpO2 and reference SaO2. The Arms must meet the 3% specification for each reprocessed pulse oximetry sensor style. 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 (%) | Masimo RD SET SpO2 Adhesive Sensors: Adult (4000 Adt), Adult & Neonate (4003) |
|---|---|
| Device 1 4000-Adt Accuracy | 1.84 |
| Device 2 4003-Neo Accuracy | 2.33 |
Collected over 2 Days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Adult Participants | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | Healthy Adult Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Healthy Adult Participants |
|---|---|
| Female | 4 |
| Male | 7 |
| Race/Ethnicity, Customized(Participants) | Healthy Adult Participants |
|---|---|
| Caucasian | 5 |
| Black | 2 |
| Asian | 2 |
| Hispanic | 0 |
| Multiethnic | 2 |
| Region of Enrollment(Participants) | Healthy Adult Participants |
|---|---|
| United States | 11 |
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