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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
120
Custom pulse oximeter with multiple wavelengths of light used to estimate blood oxygen levels.
University of North Carolina at Chapel Hill Hospitals
Chapel Hill, North Carolina, United States
RECRUITINGAccuracy 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).
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