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临床试验/NCT07370623
NCT07370623招募中不适用

Development of an AI Assessment System for Pediatric Respiratory Distress : A Prospective Study

Samsung Medical Center3 个研究点 分布在 1 个国家目标入组 2,200 人开始时间: 2025年10月28日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
2,200
试验地点
3
主要终点
Accuracy of automated respiratory pattern assessment

研究概览

简要总结

This is a multicenter, prospective observational study designed to collect clinical data for the development of a vision-language model-based artificial intelligence system for automated assessment of pediatric respiratory patterns.

The study enrolls pediatric patients aged 0 to 12 years who present to the pediatric emergency departments of participating institutions. Clinical and visual respiratory data are collected along with baseline clinical characteristics, including sex, age, body weight, height, presenting symptoms recorded at emergency department arrival, initial vital signs (body temperature, pulse rate, respiratory rate, blood pressure, and oxygen saturation), severity at presentation assessed by the Korean Triage and Acuity Scale (KTAS), emergency department management and outcomes such as hospital admission or discharge, and other relevant clinical information.

These data are used for cohort characterization and for the development and evaluation of an AI-based system that aims to automatically analyze pediatric respiratory patterns and support objective respiratory assessment in pediatric emergency care.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients aged 0 to 12 years who present to participating pediatric emergency departments.
  • Patients for whom clinical data, including basic demographic characteristics (e.g., age, body weight), severity at presentation (e.g., KTAS level), vital signs, emergency department management and outcomes, as well as visual respiratory data, are available during emergency care.

排除标准

  • Patients outside the specified age range.
  • Patients with insufficient or poor-quality clinical or visual respiratory data.
  • Patients whose data cannot be used due to withdrawal of consent or regulatory restrictions.

研究组 & 干预措施

Pediatric Emergency Department Patients

Children aged 0 to 12 years presenting to the pediatric emergency departments of participating institutions. Clinical and visual respiratory data are collected along with baseline clinical characteristics (e.g., age, body weight, height), presenting symptoms, initial vital signs, severity at presentation assessed by the Korean Triage and Acuity Scale (KTAS), and emergency department management, and outcomes such as admission or discharge. All data are collected as part of routine clinical care and used for observational analysis and model development.

结局指标

主要结局

Accuracy of automated respiratory pattern assessment

时间窗: From study start through study completion (up to December 2027)

Performance of a vision-language model-based system in assessing pediatric respiratory patterns using clinical and visual respiratory data collected in pediatric emergency departments.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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