Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)
Masimo Corporation
Summary
The objective of this study is to evaluate the performance of Masimo RD SET® SpO2 sensors in subjects with light and dark skin pigmentation in the intensive care therapeutic area.
Eligibility
- Age range
- 18–89 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subject is 18 years of age or older. * Subject is receiving care in an intensive care unit. * Subject with an arterial catheter in place. * Subject is experiencing hypoxemia as defined by 1) need for supplement oxygen or 2) peripheral oxygenation ≤ 94% on room air Exclusion Criteria: * Subjects in whom pulse oximetry cannot be reliably performed on both the third and fourth digit on the hand ipsilateral to the arterial line, precluding application of the sensor (e.g., amputation and deformity). * Subjects with a skin condition affecting the digits, where the sensor is…
Interventions
- DeviceRD SET Sensor
All subjects are enrolled into this arm and will have Sp02 measurements obtained.
Location
- Medical University of South CarolinaCharleston, South Carolina