The PRE-VAIL Study

Jilin University

Status: Not yet enrolling

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

Treatments: Procedure: Enteral nutrition is reduced before the prone position

Study type: Interventional

Funder types: Other

Identifiers

NCT07176624

The PRE-VAIL Study

Details and patient eligibility

About

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

Full 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

Enrollment: 259 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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259 participants in 2 patient groups

Enteral nutrition reduction group

Experimental group

Description:

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:

Procedure: Enteral nutrition is reduced before the prone position

Conventional feeding group

No Intervention group

Description:

Do not reduce the feeding speed before the prone position and continue to feed at the original speed