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临床试验/NCT03976167
NCT03976167已完成不适用

Oxygen Administration During Bronchoscopy in Children, High Flow and Common Nasal Cannula: a Randomized Controled Trial

Hospital Son Espases0 个研究点目标入组 108 人开始时间: 2015年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
108
主要终点
Oxygen desaturation

研究概览

简要总结

Randomized controled trial to compare oxygen desaturation during fiberoptic bronchoscopy using oxygen administered with nasal prongs and high flow nasal cannula. Drops in oxygen saturation are frequent during bronchoscopy and limit the procedure compromising patient security. The investigator's aim is to contribute to select better way of oxygen administration which could prevent desaturations during bronchoscopy in children.

研究设计

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

入排标准

年龄范围
29 Days 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • elective flexible bronchoscopy

排除标准

  • admitted in Neonatal intensive care
  • previous respiratory support: oxygen any device, non invasive or invasive ventilation
  • patient who may benefit with continuous positive pressure during procedure

研究组 & 干预措施

Common nasal cannula

Active Comparator

Oxygen administration up to 4 liters according defined protocol

干预措施: Oxygen administration with Common nasal cannula (Device)

High flow nasal cannula

Experimental

Oxygen administered with high flow nasal cannula according child weight and protocol designed for this study

干预措施: Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel (Device)

结局指标

主要结局

Oxygen desaturation

时间窗: Trough study completion, an average of 2 years

Number of patients with Oxygen saturation under 94% during bronchoscopy

次要结局

  • Apnea(Trough study completion, an average of 2 years)
  • Moderate oxygen desaturations(Trough study completion, an average of 2 years)
  • Severe oxygen desaturations(Trough study completion, an average of 2 years)
  • Bradycardia(Trough study completion, an average of 2 years)
  • Tachypnea(Trough study completion, an average of 2 years)

研究者

发起方
Hospital Son Espases
申办方类型
Other
责任方
Sponsor

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