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

NCT06432881 | Recruiting FDA Device

• 1 other identifier: GOOD0001
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  Approximately 30 minutes

Study Arms (1)

RD SET Sensor

EXPERIMENTAL

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

Device: RD SET Sensor

Interventions

RD SET Sensor DEVICE

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

RD SET Sensor

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chelsea Frank

CONTACT

949-297-7000; clinicalresearchdept@masimo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: May 29, 2024
• Study Start: January 8, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-04

Locations

US (1)