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)

What this Trial Is About

Researchers are studying whether reducing the amount of enteral nutrition before placing patients with severe acute respiratory distress syndrome (ARDS) in the prone position improves clinical outcomes. This trial focuses on patients who are mechanically ventilated and have moderate to severe ARDS. The study aims to clarify if adjusting feeding before prone positioning affects intragastric pressure and related complications during intensive care. Participants are randomly assigned to one of two groups. In the experimental group, before prone positioning, gastric contents are aspirated and the enteral nutrition dose is reduced based on stomach residue: less than 200ml results in a one-third reduction, 200-500ml leads to halving the nutrition, and above 500ml causes feeding to stop with consideration for post-pyloric feeding. The control group continues feeding at the original rate without reduction. This is a double-blind, multicenter randomized controlled trial. During the study, researchers monitor the incidence and frequency of gastric retention while patients are prone, diarrhea occurrence, interruptions in feeding, ventilator-associated pneumonia, nutrition compliance, ultrasound measurements of the stomach, ICU length of stay, and mortality rates at various time points up to 180 days. Participants are assessed within 7 days of ICU admission and followed for outcomes including up to 180 days post-admission. The study begins shortly after ICU admission and continues during the intensive care period.

The PRE-VAIL Study