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

NCT07799454 | Recruiting FDA Device

• 2 other identifiers: 24-19702024-TRG-0030
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoxemia

Keywords

Pulse Oximetry

Outcome Measures

Primary Outcomes (1)

• Accuracy of MABOS by Comparing SpO2 Percent Blood Oxygen Saturation to SaO2 Percent Blood Oxygen Saturation Utilizing ARMS Calculation Calculation

  Validate the accuracy of the novel MABOS pulse oximeter against the oxygen saturation of arterial blood in critically ill patients across a range of blood oxygen levels. This will be reported as the R-squared value of the regression fitting the raw oximeter data to the gold standard arterial oxygen measurements (SaO2), as well as an Accuracy-Root Mean Square (ARMS) value (unit: %).

  From enrollment (placement of device) to the end of the study (when 24 hours have elapsed since placement of the device).

Secondary Outcomes (2)

• MABOS' Epidermal Melanin Estimation Accuracy comparing True Melanin Concentration (arbitrary units) to Estimated Melanin Concentration (arbitrary units) using the RMSE Calculation

  From enrollment (placement of device) to the end of the study (when 24 hours have elapsed since placement of the device).

• Comparable Accuracy between MABOS and existing pulse oximeter devices using ARMS calculation

  From enrollment (placement of device) to the end of the study (when 24 hours have elapsed since placement of the device).

Study Arms (1)

MABOS

EXPERIMENTAL

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.

Device: MABOS

Interventions

MABOS DEVICE

Custom pulse oximeter with multiple wavelengths of light used to estimate blood oxygen levels.

MABOS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ranges from 18 to 85 years.
• Individuals admitted to one of UNC Hospital's intensive care units (Medical Intensive Care Unit or Cardiovascular and Thoracic Intensive Care Unit).
• Individuals with a medical condition necessitating a minimum of two arterial blood gas measurements within a 24-hour period.
• Participant, or Legally Authorized Representative (LAR) must be able to read, write, and speak English fluently.

You may not qualify if:

• History of active (clinically significant) skin disorders that make skin vulnerable to contact with conventional electronic devices.
• History of allergic response to silicones, adhesives (such as 3M Tegaderm), or acetone.
• Broken, damaged or irritated skin or rashes near the sensor application sites.
• Presence of tattoos on the fingers, hands, or forearms.
• History of a genetic condition or skin disorder that variably impacts the amount of melanin pigmentation (e.g., Vitiligo).
• Pregnant or lactating individuals
• Individuals given methylene blue within the last 24 hours or Hydroxocobalamin within the last 2 weeks.
• Individuals experiencing carbon monoxide poisoning.
• History of conditions that may affect ABG readings (e.g., lipemic specimens).
• History of hematological conditions affecting red blood cell morphology (e.g., sickle cell disease)
• Patients on Venoarterial extracorporeal membrane oxygenation (VA-ECMO), durable left ventricular assist device (LVAD), or Impella.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill Hospitals

Chapel Hill, North Carolina, 27514, United States

RECRUITING

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

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

Study Officials

• Wubin Bai, Ph.D.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arjun Putcha, M.S.

CONTACT

704-954-4398; arjun22@live.unc.edu

Study Design

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

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: September 2, 2026
• Study Start: January 6, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: September 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)