Enteral Nutrition Delivery in Prone Position Ventilated Patients With Moderate to Severe ARDS

Официальное название

Enteral Nutrition Delivery in Prone Position Ventilated Patients With Moderate to Severe Acute Respiratory Distress Syndrome: a Randomized Controlled Trial

Обзор

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.

Вмешательства

• Процедура enteral nutrition through nasojejunal tube
  place nasojejunal tube for enteral nutrition
• Процедура enteral nutrition through nasogastric tube
  place nasogastric tube for enteral nutrition

Первичные конечные точки

• Cumulative Enteral Nutrition intake to target ratio [Срок оценки: follow-up till 7-day]

Вторичные конечные точки (8)

• Incidence of new Infections [Срок оценки: follow-up till 28-day]
• Ventilator-free days within 28 days [Срок оценки: follow-up till 28-day]
• ICU Length of Stay [Срок оценки: up to 24 weeks]
• ICU Mortality Rate [Срок оценки: up to 24 weeks]
• 28-Day Mortality Rate [Срок оценки: 28 days]
• 60-Day Mortality Rate [Срок оценки: 60 days]
• Incidence Rate of Enteral Nutrition Intolerance [Срок оценки: 28 days]
• Daily Enteral Nutrition Intake Rate [Срок оценки: 7 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongda hospital, Southeast university — Нанкин

Идентификаторы

NCT: NCT07362537 · 20231030 prone nutrition

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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