PRE-VAIL: reducing enteral feeding before prone positioning for severe ARDS
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)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 259 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Hospital of Jilin University Academic / other |
| Locations | 1 site (Changchun, Jilin) |
| Trial ID | NCT07176624 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Small studies and clinical reports have reported mixed findings about feeding during prone positioning, and randomized evidence on pre-prone feeding reduction is limited.
Eligibility criteria
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 this trial is running
Changchun, Jilin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.