Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment259 (estimated)
SponsorThe First Hospital of Jilin University
Academic / other
Locations1 site (Changchun, Jilin)
StatusRecruiting
StartedSeptember 14, 2025
Main results expectedAugust 20, 2027
Study endsFebruary 20, 2028
Registry record updatedFebruary 9, 2026
Trial IDNCT07176624 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.