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NCT07799454NARecruiting

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

University of North Carolina, Chapel Hill

Start Date

1/6/2026

Completion Date

12/15/2026

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.

Eligibility Criteria

Age Range: 18 years to 85 years

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.

Interventions

DEVICE

MABOS

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Conditions

Hypoxemia

Locations

University of North Carolina at Chapel Hill Hospitals

Chapel Hill, North Carolina 27514

United States