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临床试验/NCT03488303
NCT03488303已完成不适用

Impedance Pneumography Measurement During Acute Airway Obstruction and Recovery Phase in Young Children

Revenio Research1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年4月12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
30
试验地点
1
主要终点
Association between clinical status and tidal breathing flow-volume (TBFV) curves

研究概览

简要总结

The purpose of this study is to evaluate the association of signals recorded and analysed with Ventica® LFTS in infants and preschoolers during acute airway obstruction/asthma exacerbation and recovery thereof for changes in the IP-derived TBFV curves within and between nights.

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
1 Year 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of acute airway obstruction or asthma exacerbation requiring inpatient treatment

排除标准

  • Need for an ICU treatment
  • Bronchiolitis
  • Pneumonia (not including viral infections)
  • Other cardiorespiratory or neurological chronic diseases or states that may significantly alter the overnight breathing pattern
  • Implanted or external active medical devices

结局指标

主要结局

Association between clinical status and tidal breathing flow-volume (TBFV) curves

时间窗: 2-4 nights while at ward

Assess the association between clinical status and changes in tidal breathing flow-volume (TBFV) curves measured overnight with Ventica(R) Lung Function Testing System

次要结局

  • Association between lung function and tidal breathing flow-volume (TBFV) curves(2-4 nights while at ward and 2 + 2 nights after discharge from hospital)
  • Association between asthma control and tidal breathing flow-volume (TBFV) curves(2 + 2 nights after discharge from hospital)

研究者

发起方
Revenio Research
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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