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)

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

Study Overview

• Status: Recruiting
• Conditions: Prone Position; Enteral Nutrition Feeding; ARDS (Moderate or Severe); Intensive Care Unit (ICU) Admission
• Intervention / Treatment: Procedure: Enteral nutrition is reduced before the prone position

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 benefit patients with severe mechanically ventilated 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

• Study Type: Interventional
• Enrollment (Estimated): 259
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Youquan Wang, M.D.; Phone Number: +8615584299391; Email: wangyq20@mails.jlu.edu.cn

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: youquan Wang; Phone Number: 15584299391; Email: wangyq20@mails.jlu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enteral nutrition reduction group; 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; 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
No Intervention: Conventional feeding group; Do not reduce the feeding speed before the prone position and continue to feed at the original speed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The frequency of gastric retention during the prone position	The number of times of gastric retention (with a single gastric residual volume > 200ml) per unit time during prone position (times per day)	Acute stage of critical illness (within 7 days of ICU)
The incidence of diarrhea during ICU stay	Having three or more loose or liquid stools per day, with a stool weight greater than 200-250g/d (or more than 250ml/d)	Acute stage of critical illness (within 7 days of ICU)
EN interruption rate	High gastric residual volume (single dose > 500ml) or serious gastrointestinal adverse events lead to the need to suspend EN administration	Acute stage of critical illness (within 7 days of ICU)
The incidence of Ventilator-associated pneumonia (VAP) among the participants	Pulmonary infectious inflammation that occurs 48 hours after the end of ventilator treatment is a type of hospital-acquired pneumonia	During the length of stay in the ICU (from day 1 to a maximum of 28 days)
Nutrition compliance rate	Whether the patient reached 80% of the nutritional (calories: 25kcal/kg/day and protein :1.3g/kcal) target on the 7th day of hospitalization in the ICU	The seventh day in the ICU
Gastric antral cross-sectional area (ACSA) measured by ultrasound after the end of prone positioning	The ultrasound cross-sectional area of the antrum of the stomach after adjusting to the normal position at the end of the prone position	After each prone position during the ICU stay
Length of stay in the ICU	The number of days spent in the ICU	During the length of stay in the ICU (from day 1 to a maximum of 180 days)
ICU mortality	Whether there was death during the ICU stay	During the length of stay in the ICU (from day 1 to a maximum of 180 days)
28-day mortality	Whether the patient died on the 28th day after being admitted to the ICU	Day 28 after being admitted to the ICU
90-day mortality	Whether the patient died on the 90th and 180th days after being admitted to the ICU	The 90th day after being admitted to the ICU
180-day mortality	Whether the patient died on the 180th day after being admitted to the ICU	Day 180 after being admitted to the ICU
The incidence of gastric retention during ICU stay	The incidence of gastric retention within 7 days of ICU hospitalization (The single gastric residual volume is greater than 200ml)	Within 1 to 7 days of hospitalization in the ICU

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2025
• Primary Completion (Estimated): August 20, 2027
• Study Completion (Estimated): February 20, 2028

Study Registration Dates

• First Submitted: July 30, 2025
• First Submitted That Met QC Criteria: September 9, 2025
• First Posted (Actual): September 16, 2025

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: ARDS; Prone position; Mechanical ventilation; Clinical outcome; Enteral nutrition; Gastric retention
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Follicular
• Other Study ID Numbers: The PRE-VAIL Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) will be available upon reasonable request. Researchers interested in obtaining the data should contact the corresponding author with a clear statement of the purpose of data access. The corresponding author will evaluate the request and determine whether access can be granted to part of the de-identified dataset.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No