RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: University of North Carolina, Chapel Hill • ClinicalTrials.gov ID: NCT07799454

Registry updated: 2026-09-02

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Description

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.

Interventions

MABOS (Device)
Custom pulse oximeter with multiple wavelengths of light used to estimate blood oxygen levels.

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Conditions

Hypoxemia

Locations

University of North Carolina at Chapel Hill Hospitals — Chapel Hill, North Carolina, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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