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

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

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.

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.