An interventional study of MABOS in Hypoxemia, sponsored by University of North Carolina, Chapel Hill. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Diagnostic
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.
1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.
This study's planned enrollment of 120 is above the median of 45 across 769 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: MABOS
Custom pulse oximeter with multiple wavelengths of light used to estimate blood oxygen levels.
Accuracy of MABOS by Comparing SpO2 Percent Blood Oxygen Saturation to SaO2 Percent Blood Oxygen Saturation Utilizing ARMS Calculation Calculation
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: %).
Time frame: From enrollment (placement of device) to the end of the study (when 24 hours have elapsed since placement of the device).
MABOS' Epidermal Melanin Estimation Accuracy comparing True Melanin Concentration (arbitrary units) to Estimated Melanin Concentration (arbitrary units) using the RMSE Calculation
Validate the accuracy of the novel MABOS pulse oximeter in differentiating skin pigmentation against the investigators' spectrophotometer across a range of skin melanin content (termed 'melanin index') and blood oxygen levels. This will be an algorithmic output transforming the oximeter output into a melanin value that compares favorably with the gold standard spectrophotometer measurements. The study team will report an R-squared value for the regression comparing the oximeter data to the gold standard measurement of skin-tone (melanin-index) as well as the Root Mean Square Error (RMSE) calculation (unit: %).
Time frame: From enrollment (placement of device) to the end of the study (when 24 hours have elapsed since placement of the device).
Comparable Accuracy between MABOS and existing pulse oximeter devices using ARMS calculation
Demonstrate that the novel MABOS pulse oximeter is non-inferior to currently available pulse oximetry devices in patients with high skin melanin content in predicting oxygen saturation of arterial blood (SpO2) across a range of blood oxygen levels. This will be reported as the R-squared value of the regression incorporating skin-tone between the raw oximeter and skin-tone data versus the gold standard arterial blood gas (ABG) readings, as well as the Accuracy-Root Mean Square calculation between devices (unit: %).
Time frame: From enrollment (placement of device) to the end of the study (when 24 hours have elapsed since placement of the device).
Plan to share: No — Since this data may form the basis for proprietary technology downstream, we will avoid sharing the raw patient data with other researchers.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of North Carolina, Chapel Hill →