NCT07799454 · University of North Carolina, Chapel Hill
Evaluation of the Melanin-Adjusted Blood Oxygen Sensor (MABOS) in ICU Settings
What this study is about
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.
View original scientific 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
DEVICE
MABOS
Custom pulse oximeter with multiple wavelengths of light used to estimate blood oxygen levels.
Primary outcome measures
Accuracy of MABOS by Comparing SpO2 Percent Blood Oxygen Saturation to SaO2 Percent Blood Oxygen Saturation Utilizing ARMS Calculation Calculation
Time frame: From enrollment (placement of device) to the end of the study (when 24 hours have elapsed since placement of the device).
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: %).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Chapel Hill, North Carolina
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 2, 2026 · Source of record for eligibility and locations