The PRE-VAIL Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Hospital of Jilin University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Enteral nutrition is reduced before the prone position

    Procedure/Surgery

    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

Treatment groups

259 Participants
are divided into 2 treatment groups
Group A: Enteral nutrition reduction groupExperimental treatment 1 intervention
Group B: Conventional feeding groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.