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

NCT ID: NCT06432881

Last Updated: 2026-02-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2026-03-01

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.

Conditions

Hypoxemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

RD SET Sensor

All subjects are enrolled into this arm and will have Sp02 measurements obtained.

Group Type: EXPERIMENTAL

RD SET Sensor

Intervention Type: DEVICE

All subjects are enrolled into this arm and will have Sp02 measurements obtained.

Interventions

RD SET Sensor

All subjects are enrolled into this arm and will have Sp02 measurements obtained.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masimo Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chelsea Frank

Role: CONTACT

clinicalresearchdept@masimo.com

949-297-7000

Facility Contacts

Chelsea Frank

Role: primary

clinicalresearchdept@masimo.com

949-297-7000

Other Identifiers

GOOD0001

Identifier Type: -

Identifier Source: org_study_id