The PRE-VAIL Study

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07176624
• Lead Sponsor: The First Hospital of Jilin University

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

Study Timeline

• Study First Submitted: 2025-07-30
• Status Verified: 2025-08
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Study Start: 2025-10-01
• Primary Completion: 2027-08-20
• Study Completion: 2028-02-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 259

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The incidence of gastric retention during prone position	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 Outcome Measures

Name	Time	Method
The frequency of gastric retention during the prone position	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)
The incidence of diarrhea during ICU stay	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)
EN interruption rate	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
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)	Pulmonary infectious inflammation that occurs 48 hours after the end of ventilator treatment is a type of hospital-acquired pneumonia
Nutrition compliance rate	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
Gastric antral cross-sectional area (ACSA) measured by ultrasound after the end of prone positioning	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
Length of stay in the ICU	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
ICU mortality	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
28-day mortality	Day 28 after being admitted to the ICU	Whether the patient died on the 28th day after being admitted to the ICU
90-day mortality	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
180-day mortality	Day 180 after being admitted to the ICU	Whether the patient died on the 180th day after being admitted to the ICU
The incidence of gastric retention during ICU stay	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)