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临床试验/NCT06270485
NCT06270485已完成不适用

Influence of Positive-End-Expiratory-Pressure (PEEP) on Cardiac Output in Mechanically Ventilated Children

Charite University, Berlin, Germany4 个研究点 分布在 2 个国家目标入组 58 人开始时间: 2023年11月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
4
主要终点
Cardiac Output

研究概览

简要总结

Interventional Trial to determine the Effect of different PEEP levels on Cardiac output and right-ventricular function in mechanically ventilated children < 5 years of age with congenital heart disease.

详细描述

Different PEEP-levels will be applied during invasive mechanical ventilation to describe Cardio-pulmonary interactions in children with congenital heart disease (CHD). An additional trial with the same study protocol is planned in a cohort of children with primarily pulmonary disease without CHD after completion of this trial. Esophageal pressure-monitoring, Ultrasound, respiratory mechanics and electrical impedance tomography will be used

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Day 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • invasive mechanical ventilation
  • congenital heart disease (biventricular anatomy)

排除标准

  • univentricular hearts

研究组 & 干预措施

ventilated children

Other

Application of different PEEP-levels during invasive mechanical ventilation

干预措施: PEEP (Procedure)

结局指标

主要结局

Cardiac Output

时间窗: 1 year

change in CO during intervention

次要结局

  • respiratory mechanics(1 year)
  • Global Strain RV (%/sec)(1year)
  • TAPSV (cm/s)(1year)
  • TAPSE (cm)(1 year)
  • Lung Compliance (ml/Min/kg)(1year)
  • EIT(1year)
  • Esophageal Pressure (mbar)(1year)

研究者

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

Jan Clausen

Dr. med. / MD

Charite University, Berlin, Germany

研究点 (4)

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