跳至主要内容
临床试验/NCT05069337
NCT05069337招募中不适用

Biobank of Lung Ultrasonography in Children Undergoing General Anesthesia

Yonsei University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年8月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
consolidation score

研究概览

简要总结

For children aged 6 months to 10 years old under general anesthesia, intraoperative lung ultrasound pictures are acquired, grades are evaluated for each pictures and machine learning is used to learn and apply it.

详细描述

  1. routine general anesthesia is performed in the selected children.
  2. After mechanical ventilation, the degree of lung atelectasis is evaluated using transthoracic lung ultrasonography in the anterior, lateral, posterior regions of the upper and lower points of both lungs(a total of 12 regions).
  3. Atelectasis is checked by the presence of B-line and juxta pleural consolidation.
  4. Machine learning is used to educate the photos of 70 people and grading system, and process is checked whether it applies well to the photos of the remaining 30 people.

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
— 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children aged 6 months to 10 years old under general anesthesia

排除标准

  • If the parents of the patient cannot communicate in Korean
  • If mechanical ventilation is not planned (for example, A1 pulley)
  • emergency operation
  • a child whose ultrasound image quality is expected to deteriorate due to diseases such as thoracic deformity, scoliosis, or rib fractures
  • If lateral position was not available

结局指标

主要结局

consolidation score

时间窗: After intubation and before the surgery start or after the surgery complete and before the extubation

Sum of the consolidation scores at 12 lesions by the lung ultrasonography

次要结局

  • B-line score(After intubation and before the surgery start or after the surgery complete and before the extubation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验