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

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

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.

Study Overview

• Status: Recruiting
• Conditions: ARDS
• Intervention / Treatment: Procedure: enteral nutrition through nasojejunal tube; Procedure: enteral nutrition through nasogastric tube

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Airan Liu, PhD; Phone Number: +8615295557466; Email: airanliu@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zhongda Hospital, Southeast University
      • Contact: Airan Liu; Phone Number: 862583262553; Email: airanliu@126.com
      • Contact: Email: airanliu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Post-pyloric feeding group; Enteral nutrition through nasojejunal tube	Procedure: enteral nutrition through nasojejunal tube; place nasojejunal tube for enteral nutrition
Active Comparator: Gastric feeding group; Enteral nutrition through nasogastric tube	Procedure: enteral nutrition through nasogastric tube; place nasogastric tube for enteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Enteral Nutrition intake to target ratio	The ratio of total calorie and protein intake through EN to target calorie and protein respectively.	follow-up till 7-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of new Infections	New infections occur after admission to ICU within 28 days after admission to this study	follow-up till 28-day
Ventilator-free days within 28 days	the number of days within a 28-day period that a patient does not require mechanical ventilation.	follow-up till 28-day
ICU Length of Stay	Duration of time a patient spends in the ICU from admission to discharge.	up to 24 weeks
ICU Mortality Rate	The proportion of patients who die in the Intensive Care Unit (ICU) of a hospital	up to 24 weeks
28-Day Mortality Rate	The proportion of patients who die within 28 days.	28 days
60-Day Mortality Rate	The proportion of patients who die within 60 days.	60 days
Incidence Rate of Enteral Nutrition Intolerance	The frequency at which patients experience intolerance to enteral feeding.	28 days
Daily Enteral Nutrition Intake Rate	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%.	7 days

Collaborators and Investigators

• Sponsor: Southeast University, China

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: ARDS; enteral nutrition; prone position ventilation
• Other Study ID Numbers: 20231030 prone nutrition

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: by email
• IPD Sharing Time Frame: Starting from the official publication of the manuscript to 1 year later
• IPD Sharing Access Criteria: collaborator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No