RecruitingNot ApplicableNCT07176624

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)

Sponsor

The First Hospital of Jilin University

Enrollment

259 participants

Start Date

Sep 14, 2025

Study Type

INTERVENTIONAL

Conditions

ARDS (Moderate or Severe)Prone Position Enteral Nutrition Feeding Intensive Care Unit (ICU) Admission

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

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria4

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

Interventions

PROCEDUREEnteral nutrition is reduced before the prone position

Before the prone position, the gastric contents are aspirated with a syringe, and the dose of enteral nutrition reduction is determined based on the different amounts of gastric residue. If the residual volume in the stomach is less than 200ml, the enteral nutrition intake will be reduced by one third. Gastric residual volume 200-500ml: Reduce enteral nutrition by half. If the residual gastric volume is greater than 500ml: Stop enteral nutrition and consider post-pyloric feeding