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NCT Number: NCT07176624

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

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Key information

Conditions

ARDS (Moderate or Severe) Enteral Nutrition Feeding Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Intensive Care Unit (ICU) Admission Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Prone Position

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location status: Recruiting

Location contact

youquan Wang

CONTACT

[email protected]

15584299391

About this 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 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. The incidence of gastric retention during prone position

    Time frame: 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.

Secondary outcomes

  1. The frequency of gastric retention during the prone position

    Time frame: Acute stage of critical illness (within 7 days of ICU)

    The number of times of gastric retention (with a single gastric residual volume > 200ml) per unit time during prone position (times per day)

  2. The incidence of diarrhea during ICU stay

    Time frame: Acute stage of critical illness (within 7 days of ICU)

    Having three or more loose or liquid stools per day, with a stool weight greater than 200-250g/d (or more than 250ml/d)

  3. EN interruption rate

    Time frame: Acute stage of critical illness (within 7 days of ICU)

    High gastric residual volume (single dose > 500ml) or serious gastrointestinal adverse events lead to the need to suspend EN administration

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

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

    Pulmonary infectious inflammation that occurs 48 hours after the end of ventilator treatment is a type of hospital-acquired pneumonia

  5. Nutrition compliance rate

    Time frame: The seventh day in the ICU

    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

  6. Gastric antral cross-sectional area (ACSA) measured by ultrasound after the end of prone positioning

    Time frame: After each prone position during the ICU stay

    The ultrasound cross-sectional area of the antrum of the stomach after adjusting to the normal position at the end of the prone position

  7. Length of stay in the ICU

    Time frame: During the length of stay in the ICU (from day 1 to a maximum of 180 days)

    The number of days spent in the ICU

  8. ICU mortality

    Time frame: During the length of stay in the ICU (from day 1 to a maximum of 180 days)

    Whether there was death during the ICU stay

  9. 28-day mortality

    Time frame: Day 28 after being admitted to the ICU

    Whether the patient died on the 28th day after being admitted to the ICU

  10. 90-day mortality

    Time frame: The 90th day after being admitted to the ICU

    Whether the patient died on the 90th and 180th days after being admitted to the ICU

  11. 180-day mortality

    Time frame: Day 180 after being admitted to the ICU

    Whether the patient died on the 180th day after being admitted to the ICU

  12. The incidence of gastric retention during ICU stay

    Time frame: Within 1 to 7 days of hospitalization in the ICU

    The incidence of gastric retention within 7 days of ICU hospitalization (The single gastric residual volume is greater than 200ml)

Study contacts

Contact information is provided by the study sponsor or research team.

Youquan Wang, M.D.

CONTACT

[email protected]

+8615584299391

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 16, 2025
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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