Recruiting

MABOS

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT07799454

Conditions

Hypoxemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MABOS

Study Details

Brief 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.

Conditions

Hypoxemia

Study ID

NCT07799454

Start date

Jan 6, 2026

Status verified date

Jun, 2026

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: MABOS

Acquisition of pulse oximeter data from the custom pulse oximeter, MABOS. Participants will have their skin-tone measured using a gold-standard spectrophotometer by a member of the study team. After this measurement, the custom pulse oximeter will be placed on a finger by a member of the study team, and will record data for the duration of the study (maximum of 24 hours). At the end of the study, the device will be removed by the study team.

Interventions

MABOS

Custom pulse oximeter with multiple wavelengths of light used to estimate blood oxygen levels.

Primary outcome measure

  • 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). ]

Central Contacts and Locations

Central contacts

Arjun Putcha, M.S.

704-954-4398arjun22@live.unc.edu

Locations

University of North Carolina at Chapel Hill Hospitals

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Arjun Putcha, M.S.

7049544398arjunputcha@gmail.com

Principal Investigator:

Wubin Bai, Ph.D.

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Sep 2, 2026

Last verified

Jun, 2026

Keywords

  • Pulse Oximetry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-09-02.