PRE-VAIL: reducing enteral feeding before prone positioning for severe ARDS
Official title: The Effect of Reducing Enteral Nutrition Before Prone Positioning on Clinical Outcomes in Mechanically Ventilated ARDS Patients: A Multicenter Randomized Controlled Trial (The PRE-VAIL Study)
Run by The First Hospital of Jilin University · NCT07176624 · Data updated 2026-11-12
This trial tests whether temporarily reducing tube feeding before turning adults with moderate-to-severe ARDS onto their stomachs lowers stomach pressure and feeding problems.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 259 (estimated) |
| Sponsor | The First Hospital of Jilin University Academic / other |
| Locations | 1 site (Changchun, Jilin) |
| Status | Recruiting |
| Started | September 14, 2025 |
| Main results expected | August 20, 2027 |
| Study ends | February 20, 2028 |
| Registry record updated | February 9, 2026 |
| Trial ID | NCT07176624 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with moderate-to-severe ARDS on mechanical ventilation who meet SOFA organ-failure criteria, are candidates for prone positioning, can receive early enteral nutrition, and are expected to remain in the ICU >48 hours.
✕Probably not a fit
Patients with contraindications to prone positioning or enteral nutrition, those expected to die within 48 hours, or pregnant patients would not be eligible and are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study enrolls adults with moderate-to-severe ARDS who are mechanically ventilated and expected to require ICU care. Patients planned for prone positioning receive either a reduced dose of enteral nutrition before being turned prone (experimental) or no reduction in enteral nutrition (control). Investigators monitor intragastric pressure, signs of gastric retention and feeding tolerance, along with safety outcomes during and after prone sessions. The trial is conducted at a single center in the ICU setting.
Why it matters
Potential benefit: If successful, this approach could reduce intragastric pressure and feeding-related complications during prone ventilation, improving safety and nutrition delivery for ventilated ARDS patients.
How similar studies have gone: Small studies and clinical reports have reported mixed findings about feeding during prone positioning, and randomized evidence on pre-prone feeding reduction is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years old * Within 24 hours of admission to the ICU, one or more organ systems have failed (the Sequential Organ Failure Assessment (SOFA) score of any single organ system is ≥2) * Meet the diagnostic criteria for moderate/severe ARDS (even after optimizing the ventilation Settings, the oxygenation index is still \< 150mmHg and PEEP is still ≥5 cm H2O) * It is expected to stay in the ICU for more than 48 hours Exclusion Criteria: * There are contraindications for the prone position * There are contraindications for EN, preventing the initiation of early EN (≤48 hours) * Expected to die within 48 hours * Pregnancy
Where it's running
-
The First Hospital of Jilin University
Changchun, Jilin, China Recruiting
Study contacts
- Study coordinator: Youquan Wang, M.D.
- Email: wangyq20@mails.jlu.edu.cn
- Phone: +8615584299391
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Single-dose inhaled rh-KGF-2 for ARDS in adults
This trial tests whether a single inhaled dose of rh-KGF-2 helps adults with ARDS who are on ventilators, using three dose levels to see which is safest and potentially most effective.
-
Using gut blood flow measurements to predict feeding intolerance in critically ill adults
This study will test whether bedside ultrasound measurements of gastrointestinal blood flow can help predict which critically ill adults receiving enteral nutrition will develop feeding intolerance.
-
Transpulmonary Pressure-Guided Ventilation for Right Heart Protection in ARDS
This study tests whether using transpulmonary pressure to guide ventilation can reduce right heart involvement in adults with pneumonia-related moderate to severe ARDS.
-
Biomarker-guided antibiotic decisions for ICU patients
This trial will test whether using a biomarker signature to guide antibiotic decisions for ICU patients who recently started antibiotics can reduce unnecessary antibiotic use without causing worse outcomes.
-
Stepwise enteral feeding plan to improve nutrition for critically ill children in the PICU.
This will try a step-by-step tube-feeding plan to see if it helps critically ill infants and children in the pediatric ICU get the nutrition they need.
-
How changing PEEP affects breathing drive and effort during pressure‑support ventilation
We will test whether changing PEEP levels changes neural respiratory drive and inspiratory effort in adults on pressure‑support ventilation for moderate‑to‑severe ARDS or acute hypoxemic respiratory failure.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.