ARDS (Moderate or Severe)NCT07176624
The PRE-VAIL Study
A study testing Enteral nutrition is reduced before the prone position in people with ARDS (Moderate or Severe) and Prone Position, run by The First Hospital of Jilin University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS (Moderate or Severe), Prone Position, Enteral Nutrition Feeding
- What is being tested?
- Enteral nutrition is reduced before the prone position
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2025to 20 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
youquan Wang, 15584299391, wangyq20@mails.jlu.edu.cn
About this study
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)
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
Read the 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
- Conditions
- ARDS (Moderate or Severe), Prone Position, Enteral Nutrition Feeding, Intensive Care Unit (ICU) Admission
- Being tested
- Enteral nutrition is reduced before the prone position
- Keywords
- ARDS, Mechanical ventilation, Prone position, Enteral nutrition, Gastric retention, Clinical outcome
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral nutrition is reduced before the prone positionProcedure or 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
| Study group | Role | What they receive |
|---|---|---|
| Enteral nutrition reduction group | Experimental | 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 Receives: Procedure: Enteral nutrition is reduced before the prone position |
| Conventional feeding group | No intervention | Do not reduce the feeding speed before the prone position and continue to feed at the original speed |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of gastric retention during prone position
The incidence of gastric retention (with a single gastric residual volume > 200ml) during prone position.
Measured: Acute stage of critical illness (within 7 days of Intensive Care Unit (ICU))
Secondary outcomes (12)
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: After each prone position during the ICU stay
Length of stay in the ICU
The number of days spent in the ICU
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Within 1 to 7 days of hospitalization in the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start14 Sep 2025
- Primary completion20 Aug 2027 (estimated)
- Study completion20 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Moderate or Severe)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 259 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176624
- Sponsor's protocol ID
- The PRE-VAIL Study
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be available upon reasonable request. Researchers interested in obtaining the data should contact the corresponding author with a clear statement of the purpose of data access. The corresponding author will evaluate the request and determine whether access can be granted to part of the de-identified dataset.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07176624
- Acronym / sponsor ID
- The PRE-VAIL Study
- Conditions
- ARDS (Moderate or Severe), Prone Position, Enteral Nutrition Feeding, Intensive Care Unit (ICU) Admission
- Keywords
- ARDS, Mechanical ventilation, Prone position, Enteral nutrition, Gastric retention, Clinical outcome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 259 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 14 Sep 2025 (actual)
- Primary completion
- 20 Aug 2027 (estimated)
- Study completion
- 20 Feb 2028 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteral nutrition reduction group | Experimental | Procedure: Enteral nutrition is reduced before the prone positionBefore 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 |
| Conventional feeding group | No intervention | –Do not reduce the feeding speed before the prone position and continue to feed at the original speed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteral nutrition is reduced before the prone positionBefore 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 | Procedure or surgery | Enteral nutrition reduction group |
Primary outcome
The incidence of gastric retention during prone position
Time frame: 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.
12 secondary outcomes
The frequency of gastric retention during the prone position
Time frame: Acute stage of critical illness (within 7 days of ICU)
The incidence of diarrhea during ICU stay
Time frame: Acute stage of critical illness (within 7 days of ICU)
EN interruption rate
Time frame: Acute stage of critical illness (within 7 days of ICU)
The incidence of Ventilator-associated pneumonia (VAP) among the participants
Time frame: During the length of stay in the ICU (from day 1 to a maximum of 28 days)
Nutrition compliance rate
Time frame: The seventh day in the ICU
Gastric antral cross-sectional area (ACSA) measured by ultrasound after the end of prone positioning
Time frame: After each prone position during the ICU stay
Length of stay in the ICU
Time frame: During the length of stay in the ICU (from day 1 to a maximum of 180 days)
ICU mortality
Time frame: During the length of stay in the ICU (from day 1 to a maximum of 180 days)
28-day mortality
Time frame: Day 28 after being admitted to the ICU
90-day mortality
Time frame: The 90th day after being admitted to the ICU
180-day mortality
Time frame: Day 180 after being admitted to the ICU
The incidence of gastric retention during ICU stay
Time frame: Within 1 to 7 days of hospitalization in the ICU
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be available upon reasonable request. Researchers interested in obtaining the data should contact the corresponding author with a clear statement of the purpose of data access. The corresponding author will evaluate the request and determine whether access can be granted to part of the de-identified dataset.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral nutrition is reduced before the prone position in people with ARDS (Moderate or Severe) and Prone Position, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youquan Wang, M.D. (+8615584299391, wangyq20@mails.jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of gastric retention during prone position (time frame: Acute stage of critical illness (within 7 days of Intensive Care Unit (ICU))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.