跳至主要内容
临床试验/NCT05440435
NCT05440435招募中不适用

Application of Mobile DR in the Diagnosis of Bone Trauma in High Cold Environment

Rongrong Hua4 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
4
主要终点
The image quality rating scale score.

研究概览

简要总结

In the high cold environment, mobile digital radiography (DR) is used to collect the imaging of bone injury patients, and the artificial intelligence diagnosis module is used to diagnose the injury. The quality of images obtained by mobile or conventional DR and the consistency between artificial intelligence and pure artificial diagnosis will be analyzed respectively. Finally, the application value of mobile DR loaded with artificial intelligence diagnosis function in high cold environment is determined.

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
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with new bone injury

排除标准

  • Life threatening.
  • Head injury and fracture.
  • There are congenital malformations in the bone injury site.

结局指标

主要结局

The image quality rating scale score.

时间窗: Immediately after inclusion in the study.

There are 24 entries in the image quality rating scale with a total score of 100 points. According to the score, there are 4 grades (A. ≥90; B. 80-89; C. 70-79; D. \<70), among which D is unqualified.

Difference of fracture detection rate (sensitivity and specificity) between artificial intelligence and expert diagnosis.

时间窗: Immediately after the diagnosis is completed.

Sensitivity is the percentage of individuals with bone injury who diagnosed by artificial intelligence or experts. Specificity is the percentage of those without bone injury who have normal diagnosis results.

次要结局

未报告次要终点

研究者

发起方
Rongrong Hua
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rongrong Hua

Principal Investigator

General Hospital of Chinese Armed Police Forces

研究点 (4)

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