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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)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07176624
Enrollment
259
Registered
2025-09-16
Start date
2025-09-14
Completion date
2028-02-20
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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

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

Interventions

PROCEDUREEnteral 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

Sponsors

The First Hospital of Jilin University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of gastric retention during prone positionAcute 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

MeasureTime frameDescription
The frequency of gastric retention during the prone positionAcute 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)
The incidence of diarrhea during ICU stayAcute 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)
The incidence of Ventilator-associated pneumonia (VAP) among the participantsDuring 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
Nutrition compliance rateThe seventh day in the ICUWhether 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
Gastric antral cross-sectional area (ACSA) measured by ultrasound after the end of prone positioningAfter each prone position during the ICU stayThe ultrasound cross-sectional area of the antrum of the stomach after adjusting to the normal position at the end of the prone position
Length of stay in the ICUDuring the length of stay in the ICU (from day 1 to a maximum of 180 days)The number of days spent in the ICU
ICU mortalityDuring the length of stay in the ICU (from day 1 to a maximum of 180 days)Whether there was death during the ICU stay
28-day mortalityDay 28 after being admitted to the ICUWhether the patient died on the 28th day after being admitted to the ICU
90-day mortalityThe 90th day after being admitted to the ICUWhether the patient died on the 90th and 180th days after being admitted to the ICU
180-day mortalityDay 180 after being admitted to the ICUWhether the patient died on the 180th day after being admitted to the ICU
EN interruption rateAcute 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
The incidence of gastric retention during ICU stayWithin 1 to 7 days of hospitalization in the ICUThe incidence of gastric retention within 7 days of ICU hospitalization (The single gastric residual volume is greater than 200ml)

Countries

China

Contacts

CONTACTYouquan Wang, M.D.
wangyq20@mails.jlu.edu.cn+8615584299391

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026