NCT07176624Recruiting
The PRE-VAIL Study
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)
Source: ClinicalTrials.gov · Last updated 9 Feb 2026
Brief summary (registry, in English)
During the prone position, there may be an increase in intragastric pressure. The investigators focus on a scientific question: Whether reducing enteral nutrition before the prone position will benefit patients with severe mechanically ventilated acute respiratory distress syndrome (ARDS). The experimental group had the enteral nutrition dose reduced before the prone position, while the control group did not have the enteral nutrition dose reduced
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 259 (estimated)
- First submitted
- 30 Jul 2025
- Start date
- 14 Sept 2025
- Primary completion date
- 20 Aug 2027
- Lead sponsor
- The First Hospital of Jilin University
- NCT number
- NCT07176624
What you commit to
- Study type: Interventional
- Planned participants: 259
- From 14 Sept 2025 to the primary completion date, 20 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.