NCT07362537 Enteral Nutrition Delivery in Prone Position Ventilated Patients With Moderate to Severe ARDS
| NCT ID | NCT07362537 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Southeast University, China |
| Condition | ARDS |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-01-20 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-01-20 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07362537 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying ARDS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07362537 currently recruiting?
Yes, NCT07362537 is actively recruiting participants. Contact the research team at airanliu@126.com for enrollment information.
Where is the NCT07362537 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07362537 clinical trial?
NCT07362537 is sponsored by Southeast University, China. The trial plans to enroll 40 participants.