Status:

NOT_YET_RECRUITING

The PRE-VAIL Study

Lead Sponsor:

The First Hospital of Jilin University

Conditions:

ARDS (Moderate or Severe)

Prone Position

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 benefi...

Detailed Description

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 benefi...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 20 2028

Estimated Enrollment :

259 Patients enrolled

Trial Details

Trial ID

NCT07176624

Start Date

December 1 2025

End Date

February 20 2028

Last Update

December 4 2025

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