Gastric versus postpyloric feeding for adults with ARDS on prone ventilation

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

This trial will test whether feeding through a stomach tube (nasogastric) or a tube placed past the stomach (nasojejunal) works better for adults with moderate to severe ARDS who are on a ventilator and positioned face-down.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Southeast University, China (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07362537 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–85 years old with moderate to severe ARDS (Berlin criteria, PaO2/FiO2 ≤200 mmHg) who require invasive mechanical ventilation and are expected to be prone ≥12 hours per day for at least three days and who are planned to receive enteral nutrition.

Not a fit: Patients with contraindications to enteral nutrition, significant hemodynamic instability or shock, life-threatening hypoxemia or hypercapnia, or inability to tolerate prone ventilation are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this trial could identify the feeding route that improves nutrition delivery and reduces complications in prone ventilated ARDS patients.

How similar studies have performed: Prior research comparing gastric and postpyloric feeding in ICU populations shows mixed results with some reduced aspiration and intolerance using postpyloric tubes, but randomized data specifically in prone ARDS patients are limited.

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.

Where this trial is running

Nanjing, Jiangsu

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

Study contacts

• Study coordinator: Airan Liu, PHD

Conditions ARDS; prone position ventilation; enteral nutrition