HypoxemiaNCT07799454
Evaluation of the Melanin-Adjusted Blood Oxygen Sensor (MABOS) in ICU Settings
A study testing MABOS in people with Hypoxemia, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypoxemia
- What is being tested?
- MABOS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina at Chapel Hill Hospitals
Chapel Hill, North Carolina, 27514
Arjun Putcha, M.S., 7049544398, arjunputcha@gmail.com
Wubin Bai, Ph.D.
About this study
Official title: 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.
- Conditions
- Hypoxemia
- Being tested
- MABOS
- Keywords
- Pulse Oximetry
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MABOSDevice
Custom pulse oximeter with multiple wavelengths of light used to estimate blood oxygen levels.
| Study group | Role | What they receive |
|---|---|---|
| MABOS | Experimental | 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. Receives: Device: MABOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: %).
Measured: From enrollment (placement of device) to the end of the study (when 24 hours have elapsed since placement of the device).
Secondary outcomes (2)
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: %).
Measured: 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: %).
Measured: From enrollment (placement of device) to the end of the study (when 24 hours have elapsed since placement of the device).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start6 Jan 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wubin Bai, Ph.D., Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799454
- Sponsor's protocol ID
- 24-1970
- Other IDs
- 2024-TRG-0030
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Since this data may form the basis for proprietary technology downstream, we will avoid sharing the raw patient data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Melanin-Adjusted Blood Oxygen Sensor (MABOS) in ICU Settings: Improving the Accuracy in Critical Conditions for Patients of Color
- ClinicalTrials.gov ID
- NCT07799454
- Acronym / sponsor ID
- 24-1970
- Conditions
- Hypoxemia
- Keywords
- Pulse Oximetry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MABOS | Experimental | Device: MABOSAcquisition 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MABOSCustom pulse oximeter with multiple wavelengths of light used to estimate blood oxygen levels. | Device | MABOS |
Primary outcome
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: %).
2 secondary outcomes
MABOS' Epidermal Melanin Estimation Accuracy comparing True Melanin Concentration (arbitrary units) to Estimated Melanin Concentration (arbitrary units) using the RMSE Calculation
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
Time frame: From enrollment (placement of device) to the end of the study (when 24 hours have elapsed since placement of the device).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No. Since this data may form the basis for proprietary technology downstream, we will avoid sharing the raw patient data with other researchers.
Related trials for Hypoxemia
Enrolling by invitation
Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring
Hypoxemia
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
Not yet recruitingObservational study
The Role of Ultrasonographic Tracheal Measurements in Predicting Hypoxemia During Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION, Hypoxemia
Not yet recruiting
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
Hypoxemia, Eldery People
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wubin Bai, Ph.D. principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MABOS in people with Hypoxemia, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arjun Putcha, M.S. (704-954-4398, arjun22@live.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.