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Recruiting Not applicable

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

NCT07362537 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-01-20
Last updated
2026-01-23

Condition(s) studied

ARDS

Investigational drug(s) / intervention(s)

enteral nutrition through nasojejunal tubeenteral nutrition through nasogastric tube

enteral nutrition through nasojejunal tube: place nasojejunal tube for enteral nutrition

enteral nutrition through nasogastric tube: place nasogastric tube for enteral nutrition

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Cumulative Enteral Nutrition intake to target ratio — follow-up till 7-day
    The ratio of total calorie and protein intake through EN to target calorie and protein respectively.

Trial sites (1)

FacilityCityRegionStatus
Zhongda hospital, Southeast university Nanjing Jiangsu Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07362537 on ClinicalTrials.gov ↗ ← All trials in China