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临床试验/NCT02439333
NCT02439333已完成不适用

Prospective Randomized Study of Nasal High Flow in Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Li Xuyan1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2015年7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
320
试验地点
1
主要终点
Treatment failure criteria

研究概览

简要总结

The main oxygen therapy to the patients with acute exacerbation of Chronic obstructive pulmonary disease, who are mild to moderate respiratory insufficiency (arterial blood gas analysis showed pH = 7.35, PO2 < 60mmHg,PaCO2>45mmHg) or have achieved the traditional noninvasive ventilation support standard but can not tolerate or reject, was nasal catheter, venturi mask and other conventional oxygen therapy. All these inaccurate inhaled oxygen concentration methods with inadequate heating and humidifying lead to poor patient tolerance and adverse reactions such as airway secretions discharge disorders. The high flow nasal respiratory therapy (Nasal high flow, NHF) utilises higher gas flow rates than conventional low-flow oxygen systems. The devices used deliver heated and humidified oxygen at a flow of up to 60 litres per minute via nasal cannulas with low level continous positive airway pressure. This study is a prospective randomized study. AECOPD patients with no severe respiratory failure are treated with NHF and conventional oxygen therapy respectively. The target is that NHF can increase the comfort degree of patients,reduce the rate of endotracheal intubation, and shorten the time of hospitalization.

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
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • AECOPD patients.
  • The results of blood gas analysis showed pH ≥7.35, PO2< 60mmHg, PaCO2> 45mmHg.

排除标准

  • The study case has been incorporated into the hospital again.
  • Refused to the NHF therapy.
  • The Glasgow score <
  • Severe organ dysfunction (including liver and kidney dysfunction, decompensated acidosis, upper gastrointestinal bleeding, DIC, etc.)

结局指标

主要结局

Treatment failure criteria

时间窗: 5 days

Patients with mild respiratory acidosis (7.25 \< pH \< 7.35) with obvious dyspnea (accessory respiratory muscle involvement, breathing rate greater than 25 beats per minute)

次要结局

  • Costs of hospitalization expenses(30 days)
  • Length of hospital stay(30 days)

研究者

发起方
Li Xuyan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Li Xuyan

Sponsor-Investigator

Beijing Chao Yang Hospital

研究点 (1)

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