Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT07362537

Enteral Nutrition Delivery in Prone Position Ventilated Patients With Moderate to Severe ARDS

Led by Southeast University, China · Updated on 2026-01-23

40

Participants Needed

1

Research Sites

40 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This pilot study is aimed to compare and assess the impact, safety, and practical utility of gastric versus postpyloric feeding in moderate to severe ARDS patients with prone position ventilation. Patients included will be randomly assigned to receive enteral nutrition either through a nasogastric tube or a nasojejunal tube. The primary endpoint is the achievement of enteral nutrition goals. Secondary endpoints include the incidence of hospital-acquired infections, the number of ventilator-free days within 28 days, ICU length of stay, ICU mortality, 28-day mortality, 60-day mortality rates, the incidence of enteral nutrition intolerance, and the rate of enteral nutrition intake.

CONDITIONS

Official Title

Enteral Nutrition Delivery in Prone Position Ventilated Patients With Moderate to Severe ARDS

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ARDS patients meeting Berlin criteria with a P/F ratio 60 200mmHg
  • Receiving invasive mechanical ventilation and needing prone ventilation for at least 12 hours daily and 3 or more days
  • Planned to receive enteral nutrition
  • Age between 18 and 85 years
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Contraindications to enteral nutrition such as severe intestinal ischemia, active upper gastrointestinal bleeding, high-output intestinal fistula without distal feeding route, abdominal compartment syndrome, severe diarrhea, intestinal obstruction
  • Shock with hemodynamic instability or tissue hypoperfusion
  • Life-threatening hypoxemia, hypercapnia, or acidosis
  • Unable to tolerate prone ventilation due to conditions like pregnancy, limb contractures, recent fractures or surgeries, pacemaker insertion within 48 hours, spinal instability, pelvic or facial fractures, difficult airway
  • Conditions preventing nasogastric or nasojejunal tube placement
  • Inability to start enteral nutrition within 48 hours
  • Use of prokinetic agents within 48 hours before enteral nutrition
  • Enteral nutrition via gastrostomy or jejunostomy
  • Expected ICU stay or survival less than 3 days
  • Refusal of further resuscitative treatment
  • Pregnant or breastfeeding women
  • Participation in other interventional clinical studies or deemed unsuitable by clinician

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Zhongda hospital, Southeast university

Nanjing, Jiangsu, China, 210009

Actively Recruiting

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Research Team

A

Airan Liu, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Enteral Nutrition Delivery in Prone Position Ventilated Patients With Moderate to Severe ARDS | DecenTrialz