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NCT Number: NCT07362537

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

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.

Recruiting

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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, etc.
  • 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 (e.g., pregnant women, 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 (e.g., esophageal rupture, 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.

Treatment and study plan

enteral nutrition through nasojejunal tube

Procedure

place nasojejunal tube for enteral nutrition

enteral nutrition through nasogastric tube

Procedure

place nasogastric tube for enteral nutrition

Primary outcomes

  1. Cumulative Enteral Nutrition intake to target ratio

    Time frame: follow-up till 7-day

    The ratio of total calorie and protein intake through EN to target calorie and protein respectively.

Secondary outcomes

  1. Incidence of new Infections

    Time frame: follow-up till 28-day

    New infections occur after admission to ICU within 28 days after admission to this study

  2. Ventilator-free days within 28 days

    Time frame: follow-up till 28-day

    the number of days within a 28-day period that a patient does not require mechanical ventilation.

  3. ICU Length of Stay

    Time frame: up to 24 weeks

    Duration of time a patient spends in the ICU from admission to discharge.

  4. ICU Mortality Rate

    Time frame: up to 24 weeks

    The proportion of patients who die in the Intensive Care Unit (ICU) of a hospital

  5. 28-Day Mortality Rate

    Time frame: 28 days

    The proportion of patients who die within 28 days.

  6. 60-Day Mortality Rate

    Time frame: 60 days

    The proportion of patients who die within 60 days.

  7. Incidence Rate of Enteral Nutrition Intolerance

    Time frame: 28 days

    The frequency at which patients experience intolerance to enteral feeding.

  8. Daily Enteral Nutrition Intake Rate

    Time frame: 7 days

    It is calculated as the total volume of enteral nutrition fed to a patient each day, divided by the total prescribed enteral nutrition for that day, multiplied by 100%.

Study contacts

Contact information is provided by the study sponsor or research team.

Airan Liu, PHD

CONTACT

[email protected]

+8615295557466

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

Enteral Nutrition Delivery in Prone Position Ventilated Patients With Moderate to Severe Acute Respiratory Distress Syndrome: a Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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