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临床试验/NCT05268263
NCT05268263已完成不适用

Evaluating the Feasibility of Artificial Intelligence Algorithms in Clinical Settings for Classification of Normal, Wheeze and Crackle Sounds Acquired From a Digital Stethoscope

Innova Smart Technologies (Pvt.) Ltd2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Clinical validation of AI models for detection of wheeze, crackles, and normal lung sounds by comparison with gold standard

研究概览

简要总结

Assessing the feasibility and testing the accuracy of the developed artificial intelligence algorithms for detection of wheezes and crackles in patients with lung pathologies in clinical settings on unseen local patient data acquired through three digital stethoscopes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Written consent provided

排除标准

  • Subject condition unstable
  • Chest wall deformity or wounds in adhesive application areas
  • Written consent not provided

结局指标

主要结局

Clinical validation of AI models for detection of wheeze, crackles, and normal lung sounds by comparison with gold standard

时间窗: 2 months

AI models will be tested for their clinical feasibility through comparison of results obtained from AI models with that of the gold standard by measuring positive and negative agreement (NPA \& PPA). The gold standard is the label given to each lung sound recording by an experienced consultant pulmonologist. The AI model is blinded to these labels and is tested independently for detection of normal lung sounds, wheezes, and crackles

Testing the accuracy of artificial intelligence models for detection of wheeze, crackles, and normal lung sounds by measuring the sensitivity and specificity

时间窗: 2 months

Artificial intelligence models are trained on lung sounds collected from three different digital stethoscopes named NoaScope, eSteth, and Littmann individually. Data from all three digital stethoscopes is also merged to train separate AI models. These trained AI models will be evaluated based on sensitivity which is the ability to correctly identify wheezes and crackles, and specificity which is the ability to correctly identify normal lung sounds. True positive (TP), true negative (TN), false positive (FP), and false-negative (FN) values will be used to calculate sensitivity \& specificity using the following expressions. Sensitivity: TP/TP+FN Specificity: TN/TN+FP

次要结局

  • Performance analysis of three digital stethoscopes: Littmann, NoaScope, and eSteth(2 months)

研究者

发起方
Innova Smart Technologies (Pvt.) Ltd
申办方类型
Other
责任方
Sponsor

研究点 (2)

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