Actively Recruiting
Enteral Nutrition Delivery in Prone Position Ventilated Patients With Moderate to Severe Acute Respiratory Distress Syndrome: a Randomized Controlled Trial
Led by Southeast University, China · Updated on 2026-01-23
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact, safety, and practical use of two methods of delivering enteral nutrition in patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) who require ventilation in the prone position. The study is designed as a pilot randomized controlled trial to compare nutrition delivered via a nasogastric tube versus a nasojejunal tube. This research aims to understand which feeding method better achieves nutrition goals and how it affects patient outcomes during prone ventilation. Participants will be randomly assigned to one of two groups: one receiving enteral nutrition through a nasojejunal tube (postpyloric feeding) and the other through a nasogastric tube (gastric feeding). The intervention involves placing the respective feeding tubes to provide nutrition. The study will monitor participants over several time frames to assess nutrition intake and clinical outcomes related to infections, ventilator use, ICU stay, and mortality rates. During the study, researchers will measure the cumulative ratio of enteral nutrition intake to target over 7 days as the primary outcome. Secondary outcomes include rates of hospital-acquired infections, ventilator-free days within 28 days, length of ICU stay, ICU mortality, and mortality rates at 28 and 60 days. The study will also track enteral nutrition intolerance and daily nutrition intake rates. Participants will be followed for up to 24 weeks for some outcomes, with detailed safety and effectiveness monitoring throughout the trial period.
CONDITIONS
Brief Title
Enteral Nutrition Delivery in Prone Position Ventilated Patients With Moderate to Severe ARDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ARDS patients who meet the Berlin criteria for ARDS and have a P/F ratio 200mmHg
- Patients receiving invasive mechanical ventilation and clinically judged to require prone ventilation, with an anticipated daily prone positioning time of 12 hours and a duration of prone ventilation therapy of 3 days
- Patients planned to receive enteral nutrition
- Age 18 and 85 years
- Consent to sign an informed consent form
You will not qualify if you...
- Contraindications to enteral nutrition such as severe intestinal ischemia, active upper gastrointestinal bleeding, high-output intestinal fistula without a distal feeding route, abdominal compartment syndrome, severe diarrhea, intestinal obstruction
- Presence of shock with hemodynamic instability (norepinephrine or equivalent vasopressor dosage 0.5ug/kg.min) or tissue hypoperfusion (lactate >3mmol/L)
- Life-threatening hypoxemia, hypercapnia, and acidosis
- Inability to tolerate prone ventilation including pregnancy, limb contractures, recent fractures, recent thoracic or abdominal surgery, pacemaker insertion within 48 hours, spinal instability, pelvic fractures, facial fractures, anticipated difficult airway
- Conditions preventing nasogastric or nasojejunal tube placement such as esophageal rupture or severe esophageal varices
- Anticipated inability to start enteral nutrition within 48 hours
- Use of prokinetic agents within 48 hours prior to starting enteral nutrition
- Enteral nutrition via gastrostomy or jejunostomy
- Expected ICU stay or survival time less than 3 days
- Patients refusing further resuscitative treatment
- Pregnant or breastfeeding women
- Patients already enrolled in other interventional clinical studies or deemed unsuitable for the study by the clinician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 3 days or as long as prone ventilation therapy continues
Participants receive enteral nutrition through either a nasojejunal tube or a nasogastric tube while undergoing prone ventilation as part of their care for moderate to severe ARDS.
Daily assessments during treatment
Duration - Up to 24 weeks
Participants are monitored for outcomes including nutrition intake, infections, ventilator-free days, ICU stay length, and mortality up to 24 weeks after treatment.
Visits and assessments at multiple time points up to 24 weeks
Trial Site Locations
Total: 1 location
1
Zhongda hospital, Southeast university
Nanjing, Jiangsu, China, 210009
Actively Recruiting
Research Team
A
Airan Liu, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here