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临床试验/NCT03431818
NCT03431818已完成不适用

Effective Fraction of Inspired Oxygen in Premature Infants Receiving Support Via Nasal Cannula

University of Miami1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2018年4月4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
35
试验地点
1
主要终点
Nasal cannula FiO2

研究概览

简要总结

The objective of this study is to determine the multifactorial relationship between the effective fraction of inspired oxygen (Effective-FiO2) and the FiO2 in the gas delivered by the nasal cannula (NC-FiO2), NC flow rate, spontaneous minute ventilation and other patient characteristics in premature infants who receive supplemental oxygen via nasal cannula (NC).

详细描述

During routine nasal cannula (NC) use in the newborn ICU, the actual fraction of oxygen inspired by the infant, i.e. the effective FiO2 (Effective-FiO2) that reaches the infant's airways, cannot be easily determined. The effective FiO2 during NC use is generally lower than the FiO2 in the gas delivered by NC at the infant's nose due to dilution with ambient gas entrained by the infants during spontaneous inspiration. The factors influencing effective FiO2 include the set FiO2 of the gas delivered by NC (NC-FiO2), the NC-flow rate, and the entrainment of ambient gas by the infant during each spontaneous inspiration. The individual contribution of each of these factors to the variability in effective-FiO2 in extreme premature infants has not been systematically evaluated.

The objective of this study is to determine the multifactorial relationship between the effective fraction of inspired oxygen (Effective-FiO2) and the FiO2 in the gas delivered by the nasal cannula (NC-FiO2), NC flow rate, spontaneous minute ventilation and other patient characteristics in premature infants who receive supplemental oxygen via nasal cannula (NC).

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Premature infants born between 23 and 30 weeks of gestational age
  • Receiving supplemental oxygen via nasal cannula
  • Parental informed consent

排除标准

  • Major congenital anomalies
  • Clinically unstable

结局指标

主要结局

Nasal cannula FiO2

时间窗: from birth upto 40 weeks corrected postmenstrual age

FiO2 necessary to maintain the effective FiO2 (measured at the hypopharynx) at the basal level at different nasal cannula flow rates.

次要结局

未报告次要终点

研究者

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

Nelson Claure

Associate Professor

University of Miami

研究点 (1)

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