Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)

Launched by MASIMO CORPORATION · May 22, 2024

Keywords

ClinConnect Summary

The INSPIRE trial is looking into how well a device called the Masimo RD SET® SpO2 sensor works for measuring oxygen levels in patients with different skin colors, specifically in intensive care settings. The goal is to see if the sensor performs similarly in people with light and dark skin, especially for those who are experiencing low oxygen levels, a condition known as hypoxemia.

To join this study, participants must be at least 18 years old, receiving care in an intensive care unit, and need extra oxygen or have low oxygen levels in their blood. However, certain conditions might prevent someone from participating, such as having skin issues on their fingers where the sensor is placed, or wearing nail polish on those fingers. If eligible, participants can expect to have the sensor applied to their fingers while they are monitored for their oxygen levels, contributing valuable information to help improve patient care for everyone.

Gender

ALL

Eligibility criteria

• 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 applied, which would preclude sensor placement as standard of care (e.g., psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.).
• • Subjects with distinct geographic variances in skin pigmentation (e.g., vitiligo) on the digit where the sensor is applied, which would preclude sensor placement as standard of care.
• • Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied.
• • Subjects with known allergic reactions to adhesive tapes.
• • Subjects with arterial catheter placed in a lower extremity.
• • Subjects not suitable for the investigation at the discretion of the investigator or the clinical team.