Melanin-Adjusted Blood Oxygen Sensor in ICU Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study evaluates the accuracy of a novel pulse oximeter, MABOS, across adults with varying skin tones who require frequent arterial blood gas measurements in intensive care settings. Participants will have skin tone measured with a spectrophotometer and will wear the MABOS device on one finger of each hand, plus a variant on an additional finger and wrist. Data from all devices will be collected continuously for up to 24 hours or until four arterial blood gas tests are obtained. Enrollment targets up to 120 adults admitted to UNC Hospitals’ ICUs. English proficiency is required for participants or their legally authorized representatives.

Why it matters

Who can join: the full rules

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 it's running

• University of North Carolina at Chapel Hill Hospitals
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Wubin Bai, Ph.D. — University of North Carolina, Chapel Hill
• Study coordinator: Arjun Putcha, M.S.
• Email: arjun22@live.unc.edu
• Phone: 704-954-4398

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.