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Recruiting NCT07176624

The PRE-VAIL Study

No phase Interventional ARDS (Moderate or Severe) Prone Position Enteral Nutrition Feeding Intensive Care Unit (ICU) Admission

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enteral nutrition is reduced before the prone position.
Who it may be relevant to
Registry conditions: ARDS (Moderate or Severe), Prone Position, Enteral Nutrition Feeding, Intensive Care Unit (ICU) Admission. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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)

Overview

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

  • 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

Primary outcome measures

  • The incidence of gastric retention during prone position [Time frame: Acute stage of critical illness (within 7 days of Intensive Care Unit (ICU))]
Secondary outcome measures (12)
  • The frequency of gastric retention during the prone position [Time frame: Acute stage of critical illness (within 7 days of ICU)]
  • The incidence of diarrhea during ICU stay [Time frame: Acute stage of critical illness (within 7 days of ICU)]
  • EN interruption rate [Time frame: Acute stage of critical illness (within 7 days of ICU)]
  • 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)]
  • Nutrition compliance rate [Time frame: The seventh day in the ICU]
  • 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]
  • 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)]
  • ICU mortality [Time frame: During the length of stay in the ICU (from day 1 to a maximum of 180 days)]
  • 28-day mortality [Time frame: Day 28 after being admitted to the ICU]
  • 90-day mortality [Time frame: The 90th day after being admitted to the ICU]
  • 180-day mortality [Time frame: Day 180 after being admitted to the ICU]
  • The incidence of gastric retention during ICU stay [Time frame: Within 1 to 7 days of hospitalization in the ICU]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Hospital of Jilin University — Changchun

Identifiers

NCT: NCT07176624 · The PRE-VAIL Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗