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

Not Applicable

Recruiting

• Conditions: Hypoxemia
• Interventions: Device: RD SET Sensor

• Registration Number: NCT06432881
• Lead Sponsor: Masimo Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-21
• Study First Submitted: 2024-02-23
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-22
• Last Update Submitted: 2024-05-22
• Study First Posted: 2024-05-29
• Last Update Posted: 2024-05-29
• Primary Completion: 2025-02-21
• Study Completion: 2025-02-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 152

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
RD SET Sensor	RD SET Sensor	All subjects are enrolled into this arm and will have Sp02 measurements obtained.

Primary Outcome Measures

Name	Time	Method
Investigation of skin pigmentation effect on performance of Masimo pulse oximetry	Approximately 30 minutes	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.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States