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

Recruiting

Evaluation of the Melanin-Adjusted Blood Oxygen Sensor (MABOS) in ICU Settings: Improving the Accuracy in Critical Conditions for Patients of Color

Who can join

Ages 18 to 85 · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: University of North Carolina, Chapel Hill · Participants: 120 · Started: Jan 6, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07799454

Locations in the U.S.

North CarolinaUniversity of North Carolina at Chapel Hill Hospitals, Chapel Hill

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.