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

Description

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 Overview

Study Details

Study overview

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.

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

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

Condition
Hypoxemia
Intervention / Treatment

-

Contacts and Locations

Charleston

Medical University of South Carolina, Charleston, South Carolina, United States, 29425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Masimo Corporation,

Study Record Dates

2025-02-21