NCT04507802Unknown不适用
Comparison of The Clinical Outcomes of Non-Invasive Ventilation by Helmet vs Facemask in Patients With Acute Respiratory Distress Syndrome
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Need for Endotracheal Intubation
研究概览
简要总结
The objective of this study is to evaluate the efficacy of noninvasive ventilation with helmet in reducing endotracheal intubation rates in comparison with Noninvasive Ventilation (NIV) facemask among patients with Acute Respiratory Distress Syndrome (ARDS)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with (Acute Respiratory Distress Syndrome) ARDS as per Berlin definition
- •Age: 18 and more
排除标准
- •Patients with altered sensorium [Glasgow Coma Scale (GCS) less than 13]
- •Pregnancy
- •Hemodynamic instability
- •Morbidly obese
- •Patients with tracheostomy
- •Severe acidosis [PH less than 7.15]
- •Patients with glaucoma
- •Patients with history of vertigo
研究组 & 干预措施
Non invasive ventilation via helmet
Experimental
Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.
干预措施: Non invasive ventilation via helmet (Device)
Non invasive ventilation via facemask
No Intervention
Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask
结局指标
主要结局
Need for Endotracheal Intubation
时间窗: 6 weeks
Number of patients requiring endotracheal intubation after application of helmet device
次要结局
- Intensive Care Unit Mortality(28 days)
- Patient Tolerability(28 days from randomization)
- Need for Proning(up to 24 weeks)
- Intensive Care Unit Length of Stay(4 weeks)
- Overall Mortality(90 days)
- Ventilator-free Days(28 days)
- Improvement in Oxygen Saturation(2 weeks)
研究者
研究点 (1)
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