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

Recruiting now · Not applicable

Conditions studied: ARDS

In brief

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.

Key facts

Study ID

NCT07362537

Run by

Southeast University, China

People needed

40

Starts

2026-01-20

Expected to finish

2026-10-31

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Zhongda hospital, Southeast university — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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