Gastric versus postpyloric feeding for adults with ARDS on prone ventilation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot randomized study will assign adults with moderate to severe ARDS who require prone mechanical ventilation to receive enteral nutrition either via a nasogastric tube or a nasojejunal tube. The primary outcome is achievement of enteral nutrition goals, and secondary outcomes include hospital-acquired infections, ventilator-free days at 28 days, ICU length of stay, ICU and 28- and 60-day mortality, feeding intolerance, and intake rates. Eligible patients must be adults expected to receive at least 12 hours per day of prone positioning for three or more days and be planned to receive enteral nutrition, while those with contraindications to enteral feeding or major hemodynamic or respiratory instability are excluded. The study is conducted at Zhongda Hospital, Southeast University, in Nanjing, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhongda hospital, Southeast university
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Airan Liu, PHD
• Email: airanliu@126.com
• Phone: +8615295557466

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.