Trials / Terminated
TerminatedNCT04889222
Effect of Skin Pigmentation and Race/Ethnicity Factors on the Accuracy of Masimo Pulse Oximeters
- Status
- Terminated
- Phase
- —
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Masimo Corporation · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer. Subgroups will be analyzed by skin pigmentation and self-identified race/ethnicity information. Study procedures follow ISO-80601-2-61:2011 standard requirements for basic safety and essential performance of pulse oximeter equipment. Arterial blood samples will be collected from subjects while undergoing a controlled desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen concentration is approximately 70%.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | INVSENSOR00050 | Noninvasive pulse oximeter sensor |
| DEVICE | RD SET SpO2 | Noninvasive pulse oximeter sensor |
Timeline
- Start date
- 2021-04-05
- Primary completion
- 2021-04-29
- Completion
- 2021-04-29
- First posted
- 2021-05-17
- Last updated
- 2022-12-01
- Results posted
- 2022-12-01
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04889222. Inclusion in this directory is not an endorsement.