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临床试验/NCT03003559
NCT03003559Unknown不适用

Comparison of High Flow Nasal Cannula vs Nasal Cannula in Mild Chronic Obstructive Pulmonary Disease Exacerbation(AECOPD)

China-Japan Friendship Hospital1 个研究点 分布在 1 个国家目标入组 328 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
328
试验地点
1
主要终点
endotracheal intubation demand rate

研究概览

简要总结

For AECOPD patients, only 8% patients ventilated by noninvasive and invasive positive pressure ventilation. Nasal cannula is the most common pattern of oxygen therapy in mild AECOPD. As a low flow oxygen therapy, nasal cannula has many disadvantages.Therefore, we design a randomized controlled trial(RCT)to explore whether HFNC would be better than nasal cannula to prevent the aggravation of respiratory failure and endotracheal intubation in mild AECOPD.

详细描述

For AECOPD patients, most of patients don't need respiratory support, only 8% patients ventilated by noninvasive and invasive positive pressure ventilation. Nasal cannula is the most common pattern of oxygen therapy in mild AECOPD. As a low flow oxygen therapy, nasal cannula has many disadvantages: discomfort, low humidity and unstable fraction of inspired oxygen(FiO2) in inspiratory gas. Therefore, we design a RCT to explore whether HFNC would be better than nasal cannula to prevent the aggravation of respiratory failure and endotracheal intubation in mild AECOPD.

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
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •AECOPD; pH≥7.35, PaCO2>45 mmHg

排除标准

  • •Need to be intubated immediately; refuse to engage in the study; severe organ dysfunction

研究组 & 干预措施

High flow nasal cannula

Experimental

High flow nasal cannula(OptiflowTM); Flow 25-60 L/min is set according to patients' comfort; FiO2 is adjusted to maintain peripheral capillary oxygen saturation(SpO2) 90-95%; temperature is set at 37.

干预措施: High flow nasal cannula (Device)

Nasal cannula

No Intervention

Nasal cannula;set oxygen flow to keep SpO2 90-95%

结局指标

主要结局

endotracheal intubation demand rate

时间窗: 90days

次要结局

  • actual endotracheal intubation rate(90days)

研究者

发起方
China-Japan Friendship Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Qingyuan Zhan

head of Pulmonary and Critical care medicine ward 4

China-Japan Friendship Hospital

研究点 (1)

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