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

NCT06159348 | Completed

• 1 other identifier: 00145719
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Anemia

Keywords

non-invasive detection

Outcome Measures

Primary Outcomes (1)

• Difference in ADA hemoglobin values compared to serum hemoglobin values

  Each participant will have their hemoglobin measured using the ADA and blood analysis. These values will then be compared to measure the difference between the ADA values and the serum values.

  24 hours

Secondary Outcomes (1)

• Incidence of hemolytic anemia

  24 hours

Study Arms (1)

Healthy adults

Participants will be adults aged 18-70, male or female

Diagnostic Test: Anemia Diagnostic Assistant (ADA); Diagnostic Test: Serum hemoglobin

Interventions

Anemia Diagnostic Assistant (ADA) DIAGNOSTIC_TEST

The Anemia Diagnostic Assistant is non-invasive and simultaneously detects 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.

Healthy adults

Serum hemoglobin DIAGNOSTIC_TEST

Venous blood will be drawn on the same day as the ADA was applied and sent to the hospital lab for hemoglobin analysis.

Healthy adults

Eligibility Criteria

• Age: 17 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be recruited from the University of Utah campus. Potential participants can be students or staff.

You may qualify if:

• Healthy adult

You may not qualify if:

• Immunocompromised subjects
• Patients with known hemolytic disease, anemia, or other chronic illness
• Patients who do not provide consent.
• Those who are students or reporting staff of investigators will be excluded.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Allison Judkins, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: November 30, 2023
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

US (1)