The PRE-VAIL Study

The First Hospital of Jilin University259 enrolled

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

259

Conditions

ARDS (Moderate or Severe)Prone Position Enteral Nutrition Feeding

Interventions

Enteral nutrition is reduced before the prone positionPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

Outcomes

Primary Outcomes

The incidence of gastric retention during prone position

The incidence of gastric retention (with a single gastric residual volume \> 200ml) during prone position.

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

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: After each prone position during the ICU stay

Length of stay in the ICU

The number of days spent in the ICU

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

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

Central Contacts

Youquan Wang, M.D.

CONTACT

+8615584299391 wangyq20@mails.jlu.edu.cn

Data from ClinicalTrials.gov

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