Evaluating how skin pigmentation affects pulse oximetry performance
Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)
This study is testing if a special oxygen sensor works equally well for people with different skin colors in the ICU who have low oxygen levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Masimo Corporation Industry-sponsored |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06432881 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Masimo RD SET® SpO2 sensors in measuring oxygen levels in patients with varying skin pigmentation in an intensive care setting. It aims to determine if skin color influences the accuracy of pulse oximetry readings in individuals experiencing hypoxemia. Participants must be adults in an ICU with an arterial catheter and low oxygen levels. The study will compare sensor performance across different skin tones to ensure reliable monitoring for all patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older receiving care in an intensive care unit with hypoxemia.
Not a fit: Patients who cannot have pulse oximetry performed reliably due to physical conditions affecting their fingers or skin will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved accuracy of pulse oximetry readings for patients with different skin pigmentation, enhancing patient care in critical situations.
How similar studies have performed: While there is limited data on this specific approach, studies addressing the impact of skin pigmentation on medical device performance have shown varying results, indicating a need for further investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Chelsea Frank
- Email: clinicalresearchdept@masimo.com
- Phone: 949-297-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.