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

Southeast University, China

Status: Enrolling

Conditions: ARDS

Treatments: Procedure: enteral nutrition through nasojejunal tube; Procedure: enteral nutrition through nasogastric tube

Study type: Interventional

Funder types: Other

Identifiers

NCT07362537

20231030 prone nutrition

Details and patient eligibility

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Post-pyloric feeding group

Experimental group

Description:

Enteral nutrition through nasojejunal tube

Treatment:

Procedure: enteral nutrition through nasojejunal tube

Gastric feeding group

Active Comparator group

Description:

Enteral nutrition through nasogastric tube

Treatment:

Procedure: enteral nutrition through nasogastric tube