Evaluation of the Melanin-Adjusted Blood Oxygen Sensor (MABOS) in ICU Settings
ConditionHypoxemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
MABOS
DeviceCustom pulse oximeter with multiple wavelengths of light used to estimate blood oxygen levels.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: MABOSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).Secondary outcomes
1
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).2
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).Sponsors and contacts
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Source ClinicalTrials.gov