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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
RD SET Sensor
DeviceAll subjects are enrolled into this arm and will have Sp02 measurements obtained.
Treatment groups
152 Participants
are divided into 1 treatment groupGroup A: RD SET SensorExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Investigation of skin pigmentation effect on performance of Masimo pulse oximetry
The study is designed to evaluate the performance of Masimo RD SET SpO2 sensors in subjects with light and dark skin pigmentation in the intensive care therapeutic area. SpO2 accuracy will be determined by calculating the ARMS value which will be reported as percent of oxygen saturated hemoglobin.
Time frame
Approximately 30 minutesSponsors and contacts
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Source ClinicalTrials.gov