A Prospective Feasibility Study to Explore the Utility of Using a Smartphone Camera to Monitor Blood Hemoglobin Levels in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 823
- 试验地点
- 1
- 主要终点
- To determine whether computational learning methods can be applied to fingernail images captured via a smartphone camera to quantify blood hemoglobin levels.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To determine whether computational learning methods can be applied to fingernail images captured via a smartphone camera to quantify blood hemoglobin levels.
时间窗: 6 months
Evaluated using the hemoglobin portion of a conventional complete blood count (CBC)
次要结局
- To determine whether computational learning methods can be applied to fingernail images captured via a smartphone camera to quantify other elements of the CBC(6 months)
- 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(6 months)