NCT04477668已完成不适用
Helmet Non-Invasive Ventilation for COVID-19 Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 322
- 试验地点
- 2
- 主要终点
- 28-day all-cause mortality
研究概览
简要总结
Study hypothesis: Non-invasive positive pressure ventilation delivered by helmet will reduce 28-day all-cause mortality in patients with suspected or confirmed severe COVID-19 pneumonia and acute hypoxemic respiratory failure
详细描述
This will be a pragmatic parallel randomized control trial that will compare helmet nonivasive ventilation with standard of care to standard of care alone in 1:1 ratio. The trial will be implemented in multiple centers.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected or confirmed COVID-19
- •Aged ≥14 years old at the participating ICU. ICUs that use other age cut-off for adult patients will adhere to their local standard (16 or 18 years)
- •Acute hypoxemic respiratory failure based on PaO2/FiO2 ratio <200 despite supplemental oxygen with a partial or non-rebreathing mask at a flow rate >10 L/min or above
- •Intact airway protective gag reflex
- •Able to follow instructions (e.g. squeeze hand on command, eye contact with care provider, stick out tongue on command, etc.)
排除标准
- •Prior intubation during this hospital admission
- •Cardiopulmonary arrest
- •Glasgow coma scale <12
- •Tracheostomy
- •Upper airway obstruction
- •Active epistaxis
- •Requirement for more than one vasopressor to maintain mean arterial pressure > 65 mm Hg
- •Pregnancy
- •Imminent intubation
- •Patients with do not intubate orders or equivalent
- •Enrolled in another trial for which co-enrolment is not approved including trials on mechanical ventilation
- •Patients already treated with helmet
- •Patients with chronic carbon dioxide retention (PaCO2 >45)
- •Previous enrolment in this trial
- •The primary cause of respiratory failure is not heart failure as judged by the treating team
结局指标
主要结局
28-day all-cause mortality
时间窗: 28 days from randomization
all cause mortality
次要结局
- ICU mortality(180 days from randomization)
- ICU free days at day 28(28 days from randomization)
- Vasopressor-free days at day 28(28 days from randomization)
- Serious adverse events (including cardiovascular events and device complications)(28 days from randomization)
- Renal replacement therapy-free days at day 28(28 days from randomization)
- Safety outcome: barotrauma(28 days from randomization)
- Hospital length of stay(180 days from randomization)
- Intubation rate within 28 days(28 days from randomization)
- Hospital mortality (censored at day 180)(180 days from randomization)
- Invasive ventilation-free days at day 28(28 days from randomization)
- Safety outcome: skin pressure ulcers(28 days from randomization)
- 180-day all-cause mortality(180 days from randomization)
- Follow-up study: 180-day 5-level EQ-5D version(180 days from randomization)
研究者
研究点 (2)
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