The Effect of Reducing Enteral Nutrition Before Prone Positioning on Clinical Outcomes in Mechanically Ventilated ARDS Patients: A Multicenter Randomized Controlled Trial (The PRE-VAIL Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 259
- 试验地点
- 1
- 主要终点
- The incidence of gastric retention during prone position
研究概览
简要总结
During the prone position, there may be an increase in intragastric pressure. The investigators focus on a scientific question: Whether reducing enteral nutrition before the prone position will benefit patients with severe mechanically ventilated acute respiratory distress syndrome (ARDS).
The experimental group had the enteral nutrition dose reduced before the prone position, while the control group did not have the enteral nutrition dose reduced
详细描述
During the prone position, there may be an increase in intragastric pressure. The investigators focus on a scientific question: Whether reducing enteral nutrition before the prone position will benefit patients with severe mechanically ventilated ARDS.
The experimental group had the enteral nutrition dose reduced before the prone position, while the control group did not have the enteral nutrition dose reduced
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
- Double (Participant, Outcomes Assessor)
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
- •Age ≥18 years old
- •Within 24 hours of admission to the ICU, one or more organ systems have failed (the Sequential Organ Failure Assessment (SOFA) score of any single organ system is ≥2)
- •Meet the diagnostic criteria for moderate/severe ARDS (even after optimizing the ventilation Settings, the oxygenation index is still < 150mmHg and PEEP is still ≥5 cm H2O)
- •It is expected to stay in the ICU for more than 48 hours
排除标准
- •There are contraindications for the prone position
- •There are contraindications for EN, preventing the initiation of early EN (≤48 hours)
- •Expected to die within 48 hours
- •Pregnancy
研究组 & 干预措施
Enteral nutrition reduction group
Before the prone position, the gastric contents are aspirated with a syringe, and the dose of enteral nutrition reduction is determined based on the different amounts of gastric residue. If the residual volume in the stomach is less than 200ml, the enteral nutrition intake will be reduced by one third. Gastric residual volume 200-500ml: Reduce enteral nutrition by half. If the residual gastric volume is greater than 500ml: Stop enteral nutrition and consider post-pyloric feeding
干预措施: Enteral nutrition is reduced before the prone position (Procedure)
Conventional feeding group
Do not reduce the feeding speed before the prone position and continue to feed at the original speed
结局指标
主要结局
The incidence of gastric retention during prone position
时间窗: Acute stage of critical illness (within 7 days of Intensive Care Unit (ICU))
The incidence of gastric retention (with a single gastric residual volume \> 200ml) during prone position.
次要结局
- The frequency of gastric retention during the prone position(Acute stage of critical illness (within 7 days of ICU))
- The incidence of diarrhea during ICU stay(Acute stage of critical illness (within 7 days of ICU))
- EN interruption rate(Acute stage of critical illness (within 7 days of ICU))
- The incidence of Ventilator-associated pneumonia (VAP) among the participants(During the length of stay in the ICU (from day 1 to a maximum of 28 days))
- Nutrition compliance rate(The seventh day in the ICU)
- Gastric antral cross-sectional area (ACSA) measured by ultrasound after the end of prone positioning(After each prone position during the ICU stay)
- Length of stay in the ICU(During the length of stay in the ICU (from day 1 to a maximum of 180 days))
- ICU mortality(During the length of stay in the ICU (from day 1 to a maximum of 180 days))
- 28-day mortality(Day 28 after being admitted to the ICU)
- 90-day mortality(The 90th day after being admitted to the ICU)
- 180-day mortality(Day 180 after being admitted to the ICU)
- The incidence of gastric retention during ICU stay(Within 1 to 7 days of hospitalization in the ICU)