Enteral Nutrition Delivery in Prone Position Ventilated Patients With Moderate to Severe Acute Respiratory Distress Syndrome: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cumulative Enteral Nutrition intake to target ratio
研究概览
简要总结
This pilot study is aimed to compare and assess the impact, safety, and practical utility of gastric versus postpyloric feeding in moderate to severe ARDS patients with prone position ventilation. Patients included will be randomly assigned to receive enteral nutrition either through a nasogastric tube or a nasojejunal tube. The primary endpoint is the achievement of enteral nutrition goals. Secondary endpoints include the incidence of hospital-acquired infections, the number of ventilator-free days within 28 days, ICU length of stay, ICU mortality, 28-day mortality, 60-day mortality rates, the incidence of enteral nutrition intolerance, and the rate of enteral nutrition intake.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ARDS patients who meet the Berlin criteria for ARDS and have a P/F ratio ≤ 200mmHg.
- •Patients receiving invasive mechanical ventilation and clinically judged to require prone ventilation, with an anticipated daily prone positioning time of ≥12 hours and a duration of prone ventilation therapy of ≥3 days.
- •Patients planned to receive enteral nutrition.
- •Age ≥18 and ≤85 years.
- •Consent to sign an informed consent form.
排除标准
- •Contraindications to enteral nutrition, such as severe intestinal ischemia, active upper gastrointestinal bleeding, high-output intestinal fistula without a distal feeding route, abdominal compartment syndrome, severe diarrhea, intestinal obstruction, etc.
- •Presence of shock with hemodynamic instability (norepinephrine or equivalent vasopressor dosage ≥0.5ug/kg.min) or tissue hypoperfusion (lactate >3mmol/L).
- •Life-threatening hypoxemia, hypercapnia, and acidosis.
- •Inability to tolerate prone ventilation (e.g., pregnant women, limb contractures, recent fractures, recent thoracic or abdominal surgery, pacemaker insertion within 48 hours, spinal instability, pelvic fractures, facial fractures, anticipated difficult airway).
- •Conditions preventing nasogastric or nasojejunal tube placement (e.g., esophageal rupture, severe esophageal varices).
- •Anticipated inability to start enteral nutrition within 48 hours.
- •Use of prokinetic agents within 48 hours prior to starting enteral nutrition.
- •Enteral nutrition via gastrostomy or jejunostomy.
- •Expected ICU stay or survival time less than 3 days.
- •Patients refusing further resuscitative treatment.
- •Pregnant or breastfeeding women.
- •Patients already enrolled in other interventional clinical studies or deemed unsuitable for the study by the clinician.
研究组 & 干预措施
Post-pyloric feeding group
Enteral nutrition through nasojejunal tube
干预措施: enteral nutrition through nasojejunal tube (Procedure)
Gastric feeding group
Enteral nutrition through nasogastric tube
干预措施: enteral nutrition through nasogastric tube (Procedure)
结局指标
主要结局
Cumulative Enteral Nutrition intake to target ratio
时间窗: follow-up till 7-day
The ratio of total calorie and protein intake through EN to target calorie and protein respectively.
次要结局
- Incidence of new Infections(follow-up till 28-day)
- Ventilator-free days within 28 days(follow-up till 28-day)
- ICU Length of Stay(up to 24 weeks)
- ICU Mortality Rate(up to 24 weeks)
- 28-Day Mortality Rate(28 days)
- 60-Day Mortality Rate(60 days)
- Incidence Rate of Enteral Nutrition Intolerance(28 days)
- Daily Enteral Nutrition Intake Rate(7 days)
研究者
Ling Liu
Professor
Southeast University, China