Helmet NIV Versus Facemask NIV in Acute Respiratory Failure: A Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Recruitment Rate
研究概览
简要总结
Non-invasive ventilation (NIV) is a form of respiratory support that has been shown to prevent invasive mechanical ventilation and reduce mortality. This study will investigate the feasibility of performing a larger study examining whether a new modality of NIV, the helmet, is superior to the current face mask in reducing mortality in patients with sudden respiratory failure.
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
- Single (Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who are admitted to the adult ICU
- •deemed to require NIV, as per the clinical team, for acute respiratory failure.
排除标准
- •with impending cardiac arrest or need for intubation
- •Glasgow coma scale <9
- •tracheostomy or upper airway obstruction
- •elevated intracranial pressure
- •untreated pneumothorax
- •who refuse endotracheal intubation (do not intubate order documented)
- •facial trauma
- •are unable to wear the helmet or facemask
- •who use NIV chronically
结局指标
主要结局
Recruitment Rate
时间窗: 1 year
Number of patients recruited to the study per centre
Consent Rate
时间窗: 1 year
Percentage of patients or SDMs approached for consent who give consent
Protocol adherence percentage
时间窗: 1 year
Adherence to pre-specified fixed protocol on how helmet interface is implemented (settings, weaning etc.) Any protocol deviations will be recorded and marked as protocol non-adherence.
次要结局
- Endotracheal intubation(28 days)
- Hospital mortality(60 days)
- Duration of invasive ventilation(Censored at 28 days)
- ICU mortality(28 days)
- Adverse events(28 days)
- ICU length of stay(Censored at 28 days)
- Duration of non-invasive ventilation(Censored at 28 days)
- Comfort(28 days)
- Hospital length of stay(Censored at 60 days)