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Clinical Trial NCT07176624 for ARDS (Moderate or Severe), Prone Position, Enteral Nutrition Feeding, Intensive Care Unit (ICU) Admission is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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The PRE-VAIL Study 259
Clinical Trial NCT07176624 is an interventional study for ARDS (Moderate or Severe), Prone Position, Enteral Nutrition Feeding, Intensive Care Unit (ICU) Admission that is recruiting. It started on 14 September 2025 with plans to enroll 259 participants. Led by The First Hospital of Jilin University, it is expected to complete by 20 February 2028. The latest data from ClinicalTrials.gov was last updated on 9 February 2026.
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 th...
Show MoreDetailed 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
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)
Conditions
ARDS (Moderate or Severe)Prone PositionEnteral Nutrition FeedingIntensive Care Unit (ICU) AdmissionOther Study IDs
- The PRE-VAIL Study
NCT ID Number
Start Date (Actual)
2025-09-14
Last Update Posted
2026-02-09
Completion Date (Estimated)
2028-02-20
Enrollment (Estimated)
259
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
ARDS
Mechanical ventilation
Prone position
Enteral nutrition
Gastric retention
Clinical outcome
Mechanical ventilation
Prone position
Enteral nutrition
Gastric retention
Clinical outcome
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalEnteral nutrition reduction group 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 ...Show More | 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 ...Show More |
No InterventionConventional feeding group Do not reduce the feeding speed before the prone position and continue to feed at the original speed | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
The incidence of gastric retention during prone position | The incidence of gastric retention (with a single gastric residual volume \> 200ml) during prone position. | Acute stage of critical illness (within 7 days of Intensive Care Unit (ICU)) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) | 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) | 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 | 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 | 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 | 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 | After each prone position during the ICU stay |
Length of stay in the ICU | The number of days spent in the ICU | 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 | 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 | 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 | 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 | 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) | Within 1 to 7 days of hospitalization in the ICU |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
The First Hospital of Jilin UniversityStudy Central Contact
Contact: Youquan Wang, M.D., +8615584299391, [email protected]
1 Study Locations in 1 Countries
Jilin
The First Hospital of Jilin University, Changchun, Jilin, 130021, China
youquan Wang, Contact, 15584299391, [email protected]
Recruiting