跳至主要内容
临床试验/NCT02074774
NCT02074774已完成不适用

Comparison of the IntellO2 - Precision Flow Automatic FiO2 Controller to Manual Control for Optimizing Oxygenation in Preterm Infants Receiving High Flow Nasal Cannula Therapy

Vapotherm, Inc.4 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
4
主要终点
Percent time in target range for oxygen saturation by pulse oximetry

研究概览

简要总结

The overall objective of this study is to demonstrate that the IntellO2 device providing automated control of fraction of inspired oxygen (FiO2) adjustments in spontaneously breathing infants with fluctuating arterial blood oxygen saturation levels is safe and efficacious in the routine clinical environment. Specifically, it is hypothesized that the IntellO2 will perform as well or better than standard practice for maintaining infants' arterial blood oxygen saturation in a target range while minimizing the exposure to elevated levels of oxygen in the inspired gas.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Preterm infants being treated with high flow nasal cannula therapy
  • A need for supplemental oxygen as demonstrated by an required FiO2 > 0.25 at enrollment
  • Requiring a flow rate of greater than 2 L/min such that the assumed inspired oxygen fraction matched delivered oxygen fraction (definition of HFNC).

排除标准

  • Major congenital abnormalities
  • Hemodynamic instability, defined as being outside of a normotensive range based on each infant's individual characteristics
  • Ongoing sepsis
  • Clinician's concern regarding stability of the infant

结局指标

主要结局

Percent time in target range for oxygen saturation by pulse oximetry

时间窗: 24 hrs

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (4)

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