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

Plain Language Summary

Simplified for easier understanding

This study — called PRE-VAIL — is testing a combination of prone positioning (lying face-down) and early nutritional support in critically ill patients with severe acute respiratory distress syndrome (ARDS) who are in the ICU. ARDS is a life-threatening condition where the lungs cannot provide enough oxygen to the body. **You may be eligible if...** - You have been admitted to the ICU within the last 24 hours with at least one failing organ system - You meet the criteria for moderate or severe ARDS — specifically, poor oxygen levels even with ventilator support (oxygenation index below 150 mmHg with PEEP of 5 cm H2O or more) - You are expected to remain in the ICU for more than 48 hours **You may NOT be eligible if...** - You have a condition that makes lying face-down (prone positioning) unsafe - You have a condition that prevents early tube feeding (enteral nutrition) - You have other contraindications defined in the study protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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