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临床试验/CTRI/2024/09/073232
CTRI/2024/09/073232尚未招募不适用

Development of Non-Invasive Screening of Haemoglobin for Anaemia Device (NISHAD) as a Point of Care Test: A pilot study

AIIMS Raipur1 个研究点 分布在 1 个国家目标入组 520 人开始时间: 2024年9月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
520
试验地点
1
主要终点
Value of Hb (by device and CBC)

研究概览

简要总结

This study will be undertaken to develop a device for non-invasive screening for anaemia. A prototype shall be developed. In the OPD/IPD, patients who have been advised Complete Blood Count (CBC) will be explained about the study. If they consent to participate, primary demographic data will be recorded and every subject (anaemic or normal) will be asked to insert their index finger in the area provided in the prototype device and keep it for few seconds. The value displayed shall be compared with the CBC reports. Data will be analysed using paired t test and significance level of p< .05 shall be considered. ROC curve will be constructed.  Area under curve, sensitivity, specificity, positive predictive value and negative predictive value shall be computed. Categorical data shall be analysed using chi square test.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 59.00 Year(s)(—)
性别
All

入选标准

  • All patients in the age group of 2 to 59 years who have been advised Complete Blood Count.

排除标准

  • Critically ill patients Patients with jaundice Patients of sickle cell disease or trait.

结局指标

主要结局

Value of Hb (by device and CBC)

时间窗: 2 months, 4 months, 6 months, 8 months, 10 months, 12 months

次要结局

  • Mean Corpuscular Volume(1 year)
  • Sensitivity(1 year)
  • Specificity(1 year)

研究者

发起方
AIIMS Raipur
申办方类型
Other [Central Government Institute Medical college and hospital]
责任方
Principal Investigator
主要研究者

Dr Arunita Tushar Jagzape

AIIMS raipur

研究点 (1)

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