跳至主要内容
临床试验/NCT02908399
NCT02908399Unknown不适用

Thermal Images on Smartphones to Diagnose Bacterial Pneumonia in Children in Pakistan

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2016年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
250
试验地点
1
主要终点
diagnosis of bacterial pneumonia

研究概览

简要总结

This is a prospective study of up to 250 participants, from birth to 18 months, who have already had a chest x-ray while a patient at the National Institute of Health (NICH) in Karachi, Pakistan. Participants will include both males and females as well as all races and ethnicities. Participants will have thermal pictures of their chest taken by trained study staff using a Smartphone and a FLIR ONE attachment. Thermal images will be read by trained radiologists to determine if bacterial pneumonia is present. Results of the thermal image will then be compared to the results of the chest x-ray. If additional images of the chest or other areas of suspected related infection are available, additional thermal images will be taken of the same location within 24 hours of the other image.

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

年龄范围
— 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 18 months or younger;
  • patient at NICH Hospital in Karachi, Pakistan;
  • had chest x-ray within last 24 hours to determine diagnosis of bacterial pneumonia;
  • consent obtained from one parent

排除标准

  • thermal image cannot be done within 24 hours of chest x-ray

研究组 & 干预措施

Thermal Imaging

Experimental

Imaging using a thermal camera

干预措施: FLIR ONE (Device)

结局指标

主要结局

diagnosis of bacterial pneumonia

时间窗: 24 hours

Pneumonia is defined as the presence of an airspace opacity, lobar consolidation, or interstitial opacities on a chest x-ray. This determination will be made by two independent radiologists blinded to each other's readings, clinical information and thermal images. If they agree that pneumonia is either present or absent, that will be the final diagnosis. If there is disagreement, a third independent, blinded radiologist will break the tie.

次要结局

  • diagnosis of additional site of infection possibly related to bacterial pneumonia(up to a maximum of 28 days after original chest x-ray to diagnose pneumonia is taken)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patricia L. Hibberd

Chief, Division of Global Health, Department of Pediatrics

Massachusetts General Hospital

研究点 (1)

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