Evaluation of the Melanin-Adjusted Blood Oxygen Sensor (MABOS) in ICU Settings

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT07799454
Status
Recruiting
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Conditions

  • Hypoxemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • MABOS — DEVICE
    Custom pulse oximeter with multiple wavelengths of light used to estimate blood oxygen levels.

Study Details

Purpose: Investigate the accuracy of the investigators' novel pulse oximeter across a broad range of skin-pigmentations and oxygen saturations. Participants: Up to 120 adult participants admitted to Medical Intensive Care, or Cardiovascular Thoracic Critical Care, Units. Procedures (methods): Participants will have their skin tone measured on each finger using a spectrophotometer. During the study, participants will wear one of the investigators' custom devices - MABOS - on one finger of each hand. Additionally, they will wear a variant of the investigators' device on an additional finger and outer side of the associated wrist. The study team will continuously acquire data from all devices until either 4 Arterial Blood Gas tests have been collected, or 24 hours have elapsed.

Key Dates

First listed
Sep 2, 2026
Start date
Jan 6, 2026
Status verified
Jun 2026
Primary completion
Dec 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: MABOS
    Acquisition of pulse oximeter data from the custom pulse oximeter, MABOS. Participants will have their skin-tone measured using a gold-standard spectrophotometer by a member of the study team. After this measurement, the custom pulse oximeter will be placed on a finger by a member of the study team, and will record data for the duration of the study (maximum of 24 hours). At the end of the study, the device will be removed by the study team.

Primary Outcome Measure

Accuracy of MABOS by Comparing SpO2 Percent Blood Oxygen Saturation to SaO2 Percent Blood Oxygen Saturation Utilizing ARMS Calculation Calculation [ Time Frame: From enrollment (placement of device) to the end of the study (when 24 hours have elapsed since placement of the device). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel Hill HospitalsChapel HillNorth Carolina27514
Arjun Putcha, M.S.
[email protected]
7049544398
Wubin Bai, Ph.D. (PRINCIPAL_INVESTIGATOR)

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By research site
University of North Carolina at Chapel Hill Hospitals· Chapel Hill, NC

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