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Effectiveness and Safety of Post-pyloric Feeding in Preventing Ventilator-Associated Pneumonia: A Multicenter, Open-Label, Randomized Controlled Clinical Trial

Effectiveness and Safety of Post-pyloric Feeding in Preventing Ventilator-Associated Pneumonia: A Multicenter, Open-Label, Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110376
Enrollment
Unknown
Registered
2025-10-13
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator-Associated Pneumonia

Interventions

Intervention Group:The disposable nasogastric tube was placed using the manual blind insertion technique, with the tip advanced distal to the horizontal part of the duodenum for post-pyloric feeding.
Control Group:The disposable nasogastric tube was routinely placed into the stomach for intragastric feeding.

Sponsors

Shenzhen's People Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. ICU patients anticipated to require invasive mechanical ventilation for>= 48 hours; 3. Indications for gastrointestinal enteral nutrition support; 4. If mechanical ventilation has already been initiated, the duration of ventilation should not exceed 6 hours; 5. The subject (or their legally authorized representative) has provided signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Persistent pneumonia or aspiration observed during direct intubation, with pulmonary infiltration confirmed by chest X-ray upon ICU admission; 2. Pre-existing lung disease that may affect accurate radiological interpretation; 3. Pregnancy; 4. Immunocompromised status: hematological malignancies, solid organ transplantation, congenital or acquired diseases causing significant immunodeficiency, or neutropenia (< 0.5 × 10^9/L); 5. Active gastrointestinal bleeding or acute phase of gastrointestinal perforation; 6. Severe esophageal varices; 7. Corrosive injuries of the esophagus or stomach; 8. Patients with cerebrospinal fluid rhinorrhea or a history of transnasal surgery; 9. Pharyngeal, esophageal stenosis, or obstruction preventing nasogastric tube insertion; 10. Allergy to feeding tube materials (e.g., polyurethane); 11. History of major abdominal surgery (e.g., esophageal, gastric, duodenal, or pancreatic surgery) or other abdominal procedures within the past month; 12. Severe cardiopulmonary dysfunction: severe hypertension, severe arrhythmias, active myocardial infarction, severe heart failure, severe asthma, or respiratory failure preventing supine positioning; 13. Enteral nutrition via jejunostomy or gastrostomy; 14. Anticipated decision for limited treatment (e.g., refusal or withdrawal of treatment) within 7 days; 15. End-of-life status; 16. Participation in other clinical trials within the past 30 days.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with at least one Ventilator-Associated Pneumonia event;

Secondary

MeasureTime frame
Cumulative Incidence of Ventilator-Associated Pneumonia ;Total Number of Ventilator-Associated Pneumonia Events;Spectrum and Proportion of Pathogenic Microorganisms in Ventilator-Associated Pneumonia;Time from Mechanical Ventilation Initiation to Ventilator-Associated Pneumonia Onset;Time to First Occurrence of Ventilator-Associated Pneumonia;Proportion of patients with at least one event of vomiting, enteral feeding intolerance, use of prokinetic agents, or diarrhea;Change in Sequential Organ Failure Assessment (SOFA) Score;Change in Clinical Pulmonary Infection Score (CPIS);Changes in Serum Albumin and C-Reactive Protein Levels During the First Week of Enteral Nutrition;Proportion of Patients with ICU-Acquired Infections (Bloodstream Infections, Catheter-Associated Urinary Tract Infections, and Other Infections);Proportion of Patients Achieving 100% of Target Energy Feeding;Cumulative Caloric Deficit from Day 0 to Day 7;Duration of Mechanical Ventilation;Ventilator-Free Days within 28 Days;Length of ICU Stay;Total Length of Hospital Stay;ICU Mortality Rate;In-Hospital Mortality Rate;28-Day Mortality Rate;

Countries

China

Contacts

Public ContactNan Chuanchuan

Shenzhen's People Hospital

nanccsz@163.com+86 136 1304 8939

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026