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

NCT07362537 | Recruiting

• 1 other identifier: 20231030 prone nutrition
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

ARDS

Keywords

ARDS; prone position ventilation; enteral nutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Incidence of new Infections

  follow-up till 28-day

• Ventilator-free days within 28 days

  follow-up till 28-day

• ICU Length of Stay

  up to 24 weeks

• ICU Mortality Rate

  up to 24 weeks

• 28-Day Mortality Rate

  28 days

Study Arms (2)

Post-pyloric feeding group

EXPERIMENTAL

Enteral nutrition through nasojejunal tube

Procedure: enteral nutrition through nasojejunal tube

Gastric feeding group

ACTIVE COMPARATOR

Enteral nutrition through nasogastric tube

Procedure: enteral nutrition through nasogastric tube

Interventions

enteral nutrition through nasojejunal tube PROCEDURE

place nasojejunal tube for enteral nutrition

Post-pyloric feeding group

enteral nutrition through nasogastric tube PROCEDURE

place nasogastric tube for enteral nutrition

Gastric feeding group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda hospital, Southeast university

Nanjing, Jiangsu, 210009, China

RECRUITING

Central Study Contacts

Airan Liu, PHD

CONTACT

+8615295557466; airanliu@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: January 23, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Starting from the official publication of the manuscript to 1 year later
• Access Criteria: collaborator

Locations

CN (1)