NCT02687074Unknown不适用
Effects of High Flow Nasal Canula on Moderate and Severe Respiratory Failure Patients
Southeast University, China0 个研究点目标入组 246 人开始时间: 2016年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 246
- 主要终点
- intubation rate on 28 days
研究概览
简要总结
Respiratory failure is the danger for the patients admitted in ICU, mechanical ventilation could save a lot of patients' life, however, it prolongs patients' ICU stay and hospital stay. High flow nasal cannula (HFNC) has advantages of PEEP effects, reducing dead space, increasing EELV and improving comfort, and it has been used to treat respiratory failure patients. In recent study, HFNC could improve mortality of respiratory failure patients with P/F<200mmHg in the subgroup. The investigators want to start a randomized controlled study to evaluate the effects of HFNC on the patients with respiratory failure.
详细描述
just as the brief summary
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years
- •patients met all four of the following criteria:
- •a respiratory rate of more than 25 breaths per minute,
- •a ratio of the partial pressure of arterial oxygen (Pao2) to the Fio2 of 300 mm Hg or less while the patient was breathing oxygen at a flow rate of 10 liters per minute or more for at least 15 minutes,
- •a partial pressure of arterial carbon dioxide (Paco2) not higher than 45 mmHg, and
- •an absence of clinical history of underlying chronic respiratory failure
排除标准
- •Paco2 of more than 45 mm Hg
- •exacerbation of asthma or chronic respiratory failure
- •cardiogenic pulmonary edema
- •severe neutropenia
- •hemodynamic instability, use of vasopressors,
- •Glasgow Coma Scale score of 12 points or less (on a scale from 3 to 15, with lower scores indicating reduced levels of consciousness)
- •contraindications to noninvasive ventilation
- •urgent need for endotracheal intubation, a do-not-intubate order, and a decision not to participate.
结局指标
主要结局
intubation rate on 28 days
时间窗: up to 28 days
次要结局
- Duration of ICU stay(date of death from any cause, whichever came first, assessed up to 90 days)
- Duration of hospital stay(date of death from any cause, whichever came first, assessed up to 90 days)
研究者
Chun Pan
Principal Investigator
Southeast University, China
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