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Clinical Trials in China / NCT07176624
Recruiting Not applicable

The PRE-VAIL Study

NCT07176624 · tracked via the Priya Life Science China tracker
Sponsor
The First Hospital of Jilin University
Phase
Not applicable
Started
2025-09-14
Last updated
2026-02-09

Condition(s) studied

ARDS (Moderate or Severe)Prone PositionEnteral Nutrition FeedingIntensive Care Unit (ICU) Admission

Investigational drug(s) / intervention(s)

Enteral nutrition is reduced before the prone position

Enteral 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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • The incidence of gastric retention during prone position — Acute stage of critical illness (within 7 days of Intensive Care Unit (ICU))
    The incidence of gastric retention (with a single gastric residual volume \> 200ml) during prone position.

Trial sites (1)

FacilityCityRegionStatus
The First Hospital of Jilin University Changchun Jilin Recruiting

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Other trials for the same condition

Robot-assisted Laparoscopic Partial Nephrectomy Via the Extraperitoneal Approach in the Prone Position Versus the Lateral Position Recruiting
Transpulmonary Pressure-guided Mechanical Ventilation Strategy in Right Ventricular Protection in Patients With ARDS Recruiting
A Single Dose, Dose Escalation Clinical Trial on the Safety, Tolerability and Efficacy of Lyophilized Powder for Inhalation of Recombinant Human Keratinocyte Growth Factor-2 (Rh-KGF-2) in The Treatment of Patients With Acute Respiratory Distress Syndrome Recruiting
Effect of Inhaled Nitric Oxide Therapy in Adults With Moderate-to-Severe Acute Respiratory Distress Syndrome Starting soon
A Multicenter Clinical Study on Protein Absorption Efficiency in Patients With Pancreatic Exocrine Insufficiency in the ICU Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07176624 on ClinicalTrials.gov ↗ ← All trials in China