Hemoglobin Easy Measurement With Optical Artificial Intelligence

Study Overview
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Brief Summary
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Blood hemoglobin levels are an extremely important measure for a large swath of medical procedures as they reflect the oxygen-carrying capacity of human blood. The gold standard measure for blood hemoglobin levels involve a venous blood draw followed by a laboratory-based complete blood count (CBC), a process which is both painful and time consuming. To date, various methodologies have been tested to either expediate the process or provide a non-invasive alternative. There remains a need to provide a quick, pain-free/non-invasive and accurate modality to measure blood hemoglobin levels. The objective of this study is to determine whether computer vision technologies can be applied to fingernail images captured via a smartphone camera to quantify blood hemoglobin levels.

Official Title
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A Prospective Feasibility Study to Explore the Utility of Using a Smartphone Camera to Monitor Blood Hemoglobin Levels in Children and Adolescents

Conditions
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Hemoglobin; Deficiency

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A patient aged 6 months to 18 years. A patient who has undergone a venous blood draw for a CBC since being admitted to the PED no more than 6 hours prior to study enrollment. Parents or legal guardian provide informed written consent. Exclusion Criteria: Patient has subungual hematoma, nail bed lacerations or avulsion injuries on both hands. Patient has total leukonychia. Patient has nail polish applied on fingernails. Patient has nailbed darkening or discoloration due to medication. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether computational learning methods can be applied to fingernail images captured via a smartphone camera to quantify blood hemoglobin levels. | Evaluated using the hemoglobin portion of a conventional complete blood count (CBC) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether computational learning methods can be applied to fingernail images captured via a smartphone camera to screen for anemia as defined by the WHO | Evaluated using the hemoglobin portion of a conventional complete blood count (CBC). Anemia cutoff for children aged 6 months to 6 years = 11 g/dL and for children aged 6-14 years = 12 g/dL. | 6 months | 
| To determine whether computational learning methods can be applied to fingernail images captured via a smartphone camera to quantify other elements of the CBC | Evaluated using the hemoglobin portion of a conventional complete blood count (CBC) | 6 months |