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Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE) | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT06432881•Masimo Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 89 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Key Dates

Start Date

January 8, 2024

Primary Completion Date

March 1, 2026

Completion Date

March 1, 2026

Last Updated

February 4, 2026

Enrollment

152

ESTIMATED participants

Conditions

Hypoxemia

Interventions

RD SET Sensor

DEVICE

Contacts

Chelsea Frank

CONTACT

949-297-7000 clinicalresearchdept@masimo.com

Health Systems and Policy Contexts of Medical Oxygen

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RECRUITING

Postoperative Respiratory and Activity Monitoring

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Health Systems and Policy Contexts of Medical Oxygen

Postoperative Respiratory and Activity Monitoring

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