Pilot Feasibility Study of a Novel Non-invasive Device for Diagnosis of Anemia - Trial NCT06159348

Timeline & Enrollment

Primary Outcome

Difference in ADA hemoglobin values compared to serum hemoglobin values

Summary

In low-resource areas of the world, anemia screening relies on analyzing a blood sample and
 is generally carried out in health facilities. Current anemia screening approaches have not
 yielded satisfactory results due to critical limitations including lack of a) reliable access
 to laboratory facilities, b) reliable non-invasive out-of-hospital screening tools for
 community health-workers, c) integration of anemia data across health systems and d)
 distinction between hemolytic and nutritional causes. Currently available non-invasive tools
 have unacceptably low accuracy and cannot distinguish between nutritional and hemolytic
 etiologies.
 
 Prototype Anemia Diagnostic Assistant (ADA)
 
 We have developed a prototype Anemia Diagnostic Assistant for non-invasive, simultaneous
 detection of two markers of anemia, blood hemoglobin and the End-Tidal carbon monoxide
 levels. The device comprises an optical sensor module and ETCO breath sampling module.
 
 The unique and significant advantage of the instrument is its ability to detect,
 independently, two orthogonal variables that are required for differential diagnosis of the
 nutritional and hemolytic anemia:
 
 1. Hemoglobin concentration using a non-invasive diffuse reflectance spectroscopy. Using
 high-fidelity, 11 wave-length spectral sensor, the device will provide optical
 quantification of hemoglobin levels. Optical hemoglobin sensing using diffused
 reflectance spectroscopy is well known, however; using traditional spectrophotometry
 instrumentation is very costly and thus impractical for this project. As a solution, we
 propose to use a validated commercially-available high accuracy 11-wavelength sensor
 within the visual and near-infrared (IR) range of the spectrum. The 11-wavelength
 spectrum will allow for sufficient accuracy in measuring the reflectance AND
 transmittance at isosbestic wavelengths on hemoglobin extinction curve as well as to
 compensate for the presence of melanin, which is a major interferant in optical
 determination of hemoglobin concentration. [9] The sensor was originally designed to
 collect data on the earlobe and/or the fingertip. Additional iterations include a sensor
 that straps around the wrist (similar to a smartwatch). Both versions of the device may
 be used in the study, and both feature standard USB or Bluetooth connectivity to
 ubiquitous mobile Android an iOS-based mobile platform .
 
 2. End-tidal carbon monoxide. Using a non-invasive probe placed in proximity to the
 nostrils, the device will measure ETCO as a proxy measure of hemolysis. ETCO measurement
 as a measure for the presence of hemolysis is well documented in the medical literature
 and is commonly used in newborns units as a screening method for the presence of
 hemolysis [7,8,10]. A positive finding (presence of elevated levels of ETCO) will then
 prompt a referral for further hospital testing.
 
 The objective of this study is to determine the hemoglobin and ETCO concentration in healthy
 volunteers using the prototype device and compare the results with the hemoglobin and ETCO
 concentrations obtained using standard of care devices and the CoSense system for the (ETCO
 measurement).

ICD-10 Classifications