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临床试验/NCT04650230
NCT04650230已完成不适用

High Flow Nasal Cannula Therapy (HFNC) Versus Nasal Positive Airway Pressure and or Nasal Positive Pressure Ventilation (NCPAP/ NPPV) in Infants With Severe Bronchiolitis

Children's Hospital of Tunis0 个研究点目标入组 268 人开始时间: 2013年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
268
主要终点
Number of participants with HFNC success

研究概览

简要总结

The purpose of the study was to test the null hypothesis that there is no difference between nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices when applied as a first non-invasive respiratory support mode for severe bronchiolitis

详细描述

The authors conducted a randomized controlled trial in the PICU of Children's hospital of Tunis. Participants aged from 7 days to 6 months, were eligible if all inclusion criteria were verified.

On admission, demographic and clinical data were collected. When a participant met the inclusion criteria, respiratory support was randomly allocated as high flow nasal cannula (HFNC) or nasal continuous positive airway pressure / nasal positive pressure ventilation (CPAP/NPPV).

Clinical parameters were monitored at treatment start and every 6 hours during the first 24 hours and then twice daily thereafter.

Participants in the HFNC group received heated and humidified gas flow with the Fisher & Paykel Healthcare HFNC system. The flow rate was usually started at the maximum flow rate for the size of cannula and a constant flow temperature of 37 °C.The flow rate will be progressively decreased when inspired fraction of oxygen (FiO2) was inferior to 30 percent (%).

Participants in the CPAP/NPPV group received for first CPAP using a neonatal ventilator. The recommended starting pressure for CPAP was +6 centimeter of water (cmH2O). Positive continuous pressure could be increased to a maximum of +8 cmH2O. Optimal positive end expiratory pressure (PEEP) was what could maintain SpO2 at 94 per cent using the lowest fraction of inspired oxygen. PEEP will be decreased progressively of 1cmH2O every 6 hours from the optimal PEEP when FiO2 was inferior to 30% and there is no increased work of breathing.

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

年龄范围
7 Days 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of bronchiolitis defined as the first viral episode of respiratory distress before 2 years of aging, presenting with rhinitis, tachypnea, cough, wheezing, prolonged expiratory time, crackles and use of accessory muscles, with or without fever, with or without infiltrate on the chest X ray
  • bronchiolitis severity Wang modified score ≥ 10

排除标准

  • recurrent wheezing
  • heart disease
  • chronic lung disease
  • neuromuscular disease
  • primary diagnosis was not bronchiolitis (pneumonia, pertussis)
  • critically ill infants who had an immediate need of intubation

结局指标

主要结局

Number of participants with HFNC success

时间窗: during hospitalization, approximatly 6 days

success was defined by no need of another respiratory support device

Number of participants with CPAP/NPPV success

时间窗: during hospitalization, approximatly 6 days

success was defined by no need of another support device

次要结局

  • rate of intubation(during hospitalization, approximatly 6 days)

研究者

发起方
Children's Hospital of Tunis
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aida Borgi

Professor

Children's Hospital of Tunis

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