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临床试验/NCT06321133
NCT06321133招募中不适用

High Flow Nasal Cannula Weaning in Acute Bronchiolitis - an Open-label Randomized Controlled Trials

Kuopio University Hospital4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
4
主要终点
Hospitalization time from randomization

研究概览

简要总结

The goal of this clinical study is to compared two different strategies to end high flow nasal cannula treatment in acute bronchiolitis. This study compared the immediate ending of high flow treatment to weaning strategy, in which the flow rate is gradually decreased. The aim is to assess if the immediate ending shortens the hospitalization time and whether it is a safe strategy.

详细描述

Acute bronchiolitis is the most common cause of hospitalization among infants in Finland, with its primary etiology being the RS- virus. Acute bronchiolitis is defined in Finland as an infant's first respiratory distress before the age of 1. There is no effective pharmacological treatment for acute bronchiolitis. High-flow nasal cannula therapy has been shown in large randomized trials to reduce the risk of intensive care unit admission for children. High-flow nasal cannulas are typically used at a flow rate of 2 liters per kilogram per minute. Despite widespread use, there is insufficient evidence to determine whether high-flow therapy should be discontinued abruptly or gradually tapered. Observational studies indicate that the majority of units opt for abrupt discontinuation. Common criteria for discontinuation include weaning off supplemental oxygen and maintaining normal oxygenation on room air for 4-6 hours. Gradual weaning has been shown in observational studies to prolong hospitalization compared to immediate cessation of therapy. In a randomized controlled trial conducted in a pediatric intensive care unit, direct discontinuation shortened the duration of treatment by up to two days. However, there have been no previous randomized trials conducted on bronchiolitis patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
0 Months 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Clinically diagnosed acute bronchiolitis
  • High flow nasal cannula treatment has lasted for at least 12 hours
  • Measured saturation 95 or more with room air
  • High flow rate is maximum 2l/kg/min
  • The treating doctors considers the infant suitable to be without high flow

排除标准

  • Major congenital anomaly of lungs, hearts or diaphragm
  • Bacterial pneumonia
  • Parents do not give consent

结局指标

主要结局

Hospitalization time from randomization

时间窗: One week

Time in hours from the randomization to the time the family leaves hospital.

次要结局

  • Overall hospitalization time(One week)
  • Treatment failures(One week)
  • Readmission rate(Seven days from discharge)

研究者

发起方
Kuopio University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilari Kuitunen

Associate Professor

Kuopio University Hospital

研究点 (4)

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