Cerebral Hypoxia Clinical Trials

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Evaluation of the Melanin-Adjusted Blood Oxygen Sensor (MABOS) in ICU Settings: Improving the Accuracy in Critical Conditions for Patients of Color

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
United States
North Carolina
University of North Carolina at Chapel Hill Hospitals
RECRUITING
Chapel Hill
Contact Information
Primary
Arjun Putcha, M.S.
arjun22@live.unc.edu
704-954-4398
Time Frame
Start Date: 2026-01-06
Estimated Completion Date: 2026-12-15
Participants
Target number of participants: 120
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov