The PRE-VAIL Study

NCT07176624 | Recruiting DMC

• 1 other identifier: The PRE-VAIL Study
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 1

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 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

Conditions

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

Keywords

ARDS; Mechanical ventilation; Prone position; Enteral nutrition; Gastric retention; Clinical outcome

Outcome Measures

Primary Outcomes (1)

• The incidence of gastric retention during prone position

  The incidence of gastric retention (with a single gastric residual volume \> 200ml) during prone position.

  Acute stage of critical illness (within 7 days of Intensive Care Unit (ICU))

Secondary Outcomes (12)

• The frequency of gastric retention during the prone position

  Acute stage of critical illness (within 7 days of ICU)

• The incidence of diarrhea during ICU stay

  Acute stage of critical illness (within 7 days of ICU)

• EN interruption rate

  Acute stage of critical illness (within 7 days of ICU)

• The incidence of Ventilator-associated pneumonia (VAP) among the participants

  During the length of stay in the ICU (from day 1 to a maximum of 28 days)

• Nutrition compliance rate

  The seventh day in the ICU

Study Arms (2)

Enteral nutrition reduction group

EXPERIMENTAL

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

Procedure: Enteral nutrition is reduced before the prone position

Conventional feeding group

NO INTERVENTION

Do not reduce the feeding speed before the prone position and continue to feed at the original speed

Interventions

Enteral nutrition is reduced before the prone position PROCEDURE

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

Enteral nutrition reduction group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Youquan Wang, M.D.

CONTACT

+8615584299391; wangyq20@mails.jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: September 16, 2025
• Study Start: September 14, 2025
• Primary Completion (Estimated): August 20, 2027
• Study Completion (Estimated): February 20, 2028
• Last Updated: February 9, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)