Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)
ConditionHypoxemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorMasimo Corporation
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- RD SET Sensor
Treatment groups
152 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov