A Wake Prone Positioning in Non-intubated Patients With Acute Hypoxemic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 244
- 主要终点
- Number of participants within intervention arm whom need endotracheal intubation.
研究概览
简要总结
Patients admitted to the ICU with severe hypoxemia are at high risk for mortality. Few therapies have been proven to improve patient outcomes or duration of mechanical ventilation e.g. low tidal volume ventilation, prone positioning, and a fluid-restrictive strategy. Prone positioning is a technique used to help patients with acute respiratory distress syndrome breathe better. There is high degree of uncertainty on its effects on clinical outcomes in non-intubated patients with acute hypoxemia and larger studies are needed.
详细描述
we plan to study the effect of prone positioning versus standard treatment in non-intubated patients with acute hypoxemia admitted at Respiratory Intensive Care Unit (RICU), Chest Department, Assiut University Hospital, Egypt.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 18 years or older who are not intubated and required at least 40% oxygen (via low- or high-flow oxygen devices) or noninvasive positive pressure ventilation.
排除标准
- •Patients will be excluded from the study if they :
- •had received invasive mechanical ventilation, had contraindications to prone positioning, are at risk of complications from prone positioning, had been self-prone positioning prior to enrollment and Pregnancy.
研究组 & 干预措施
Group-1: prone positioning + standard treatment
Patients randomized to the intervention group will be subjected to awake prone positioning. The target duration of prone positioning is 8 h/d to 10 h/d with 2 to 3 breaks (1-2 hours each), if needed. Daily prone positioning sessions will be protocolized to continue until 1 of the following stopping criteria is met: a relative improvement in the FIO2 requirement by 40% from the baseline value that sustained for 24 hours; endotracheal intubation; or discharge from the ICU. The treating team will supervise patients who could move themselves during the prone positioning process and assist the patients with positioning as required.
干预措施: prone positioning (Other)
Group-2: Standard treatment only
Patients randomized to the control group, and their treating team, will be informed of their group assignment. Nurses instruct patients not to position themselves in the prone position.
结局指标
主要结局
Number of participants within intervention arm whom need endotracheal intubation.
时间窗: 30 days of randomization.
Intubation is needed when one major criterion including (cardiac or respiratory arrest; hemodynamic instability, life threatening arrhythmias, inability to protect the airway; coma or psychomotor agitation and intolerance to NIV interface; and two of the following minor criteria: RR\> 35/min., PaO2/FiO2\<200 mmHg, and respiratory acidosis (pH\<7.30)).
次要结局
- Number of days on a ventilator.(30 days of randomization.)
- mortality.(60 days of randomization.)
- Length of hospital stay in days.(60 days of randomization.)
- Length of ICU stay in days.(60 days of randomization.)
研究者
Montaser Gamal Ahmed
lecturer
Assiut University