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

Hypoxemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06432881
• Other study ID #: GOOD0001
• Status: Recruiting
• Phase: N/A
• Start date: December 21, 2023
• Est. completion date: February 21, 2025

Study information

• Verified date: May 2024
• Source: Masimo Corporation
• Contact: Chelsea Frank
• Phone: 949-297-7000
• Email: clinicalresearchdept[@]masimo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: February 21, 2025
• Est. primary completion date: February 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypoxemia
• Hypoxia

Intervention

Device:
• RD SET Sensor
All subjects are enrolled into this arm and will have Sp02 measurements obtained.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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