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临床试验/NCT04542096
NCT04542096已完成不适用

Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of Very Low Birth Weight (<1500 G) Neonates Using Electric Impedance Tomography

Vilnius University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2020年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
To evaluate the lung aeration properties of very low birth weight neonates using different respiratory therapy methods and regimens.

研究概览

简要总结

Electric Impedance Tomography (EIT) is a lung monitoring technique based on the injection of small currents and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance change in a slice of the thorax. It is a real time, radiation free, non-invasive and portable. Neonatal respiratory distress syndrome (RDS) is a respiratory disorder resulting from immaturity of the lung structure and lack of surfactant. It is one the most common conditions in premature infants. Many of these infants require either invasive or non-invasive respiratory support. The goal of the study is to investigate the dynamic changes in pulmonary aeration during assisted breathing in very low birthweight preterm infants using pulmonary electrical impedance tomography. Currently most widely used methods to assess respiratory lung function are either invasive and/or indirect (ABG, pulse oximetry, transcutaneous pCO2 measurement), lacks temporal resolution (lung ultrasound) or emit ionizing radiation (CT). EIT provides information on regional lung aeration without the aforementioned shortcomings.

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
22 Weeks 至 36 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Gestational age <32 weeks OR birthweight <1500 g.
  • Need of respiratory therapy (invasive or non-invasive)
  • Parental consent.

排除标准

  • patient does not meet all of the above listed inclusion criteria
  • patients with a pacemaker
  • patients with skin damage/abrasions at the EIT device belt area
  • newborns with significant thoracic deformity

结局指标

主要结局

To evaluate the lung aeration properties of very low birth weight neonates using different respiratory therapy methods and regimens.

时间窗: 1 - 5 days.

Lung aeration and ventilation will be assessed with EIT. Several methods will be used and compared, based on pixel information of lung aeration, and pressure-volume characteristics, regional ventilation distribution and etc.

次要结局

  • To evaluate the characteristics of lung aeration during routine nursing care in preterm very low birthweight infants receiving respiratory support.(1 - 5 days.)
  • To compare lung aeration and regional ventilation distribution between two non-invasive respiratory therapies, constant positive pressure and high-flow nasal cannula in very low birthweight neonates.(1 - 5 days.)

研究者

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

Arunas Liubsys

Arūnas Liubšys MD, PhD

Vilnius University

研究点 (1)

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