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临床试验/NCT03845244
NCT03845244已完成不适用

Simultaneous Reduction Versus Flow or Fraction of Inspired Oxygen Reduction First in Patients Ready to Wean From High Flow Nasal Cannula Oxygen Therapy: a Randomized Controlled Trial

Seoul National University Hospital2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2019年1月24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
100
试验地点
2
主要终点
Time to weaning success

研究概览

简要总结

High flow nasal cannula oxygen therapy has been widely used in critically ill patients. Despite effectiveness of high flow nasal cannula as a treatment, optimal methods to withdrawal high flow nasal cannula after recovery from preexisting conditions has not been investigated to date. In this study, we will evaluate the efficacy and safety of three different weaning methods in patients with high flow nasal cannula oxygen therapy.

详细描述

Comparison of three weaning strategies: flow reduction first versus fraction of inspired oxygen (FiO2) first versus simultaneous reduction

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patients applying high flow nasal cannula and satisfying the following weaning criteria.
  • Patient who has recovered from the underlying condition
  • No signs of respiratory distress like agitation, diaphoresis or anxiety
  • Arterial pH ≥ 7.35, SpO2 > 90% on FiO2 ≤ 0.5
  • Respiratory rate ≤ 25/min, Heart rate ≤120/min, Systolic blood pressure ≥ 90mmHg

排除标准

  • Severe hypercapnia (pH <7.25)
  • Respiratory arrest requiring tracheal intubation
  • Cardiac arrest, acute coronary syndrome or life threatening arrhythmias
  • Failure of more than two organs
  • Recent trauma or burns of the neck and face
  • Non- cooperation
  • Pregnancy
  • Refusal of treatment

结局指标

主要结局

Time to weaning success

时间窗: up to 2 weeks

The time to successfully remaining off high flow nasal cannula

次要结局

  • weaning success or failure rate(up to 2 weeks)
  • change of arterial partial pressure of oxygen, carbon dioxide, and pH(up to 2 weeks)
  • intolerance rate(up to 2 weeks)
  • hospital length of stay(during hospital admission, up to 12 weeks)
  • In-hospital mortality(during hospital admission, up to 12 weeks)

研究者

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

Eun Sun Kim

Associate professor

Seoul National University Bundang Hospital

研究点 (2)

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