The PRE-VAIL Study (NCT07176624) | Clinical Trial Compass
RecruitingNot Applicable
The PRE-VAIL Study
China259 participantsStarted 2025-09-14
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is specifically looking at gastric retention — meaning food or fluid backing up in the stomach — during prone positioning, can you explain how being face-down on a ventilator in the ICU might affect how my body tolerates tube feeding, and why that matters for my care?
2This trial isn't testing a new drug or device, but rather observing what happens with nutrition during prone positioning for moderate or severe ARDS — does that mean there's no experimental treatment involved, and what, if anything, would be different about my care if I were enrolled?
3Given that this is listed as 'Phase NA,' which suggests it's an observational or non-interventional study, what are the potential risks or burdens of participating compared to just receiving standard ARDS care in the ICU?
4If prone positioning is already part of my treatment plan for ARDS, would joining this study change how or when I'm proned, or how my tube feeding is managed, in any way?
5Are there other ongoing studies or standard-of-care approaches for managing nutrition during prone positioning that I should know about, so we can weigh whether participating in this observational study is the right choice for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of gastric retention during prone position
Timeframe: Acute stage of critical illness (within 7 days of Intensive Care Unit (ICU))