ARDS
Conditions
Keywords
ARDS, prone position ventilation, enteral nutrition
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.
Interventions
PROCEDUREenteral nutrition through nasojejunal tube
place nasojejunal tube for enteral nutrition
PROCEDUREenteral nutrition through nasogastric tube
place nasogastric tube for enteral nutrition
Sponsors
Southeast University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Enteral Nutrition intake to target ratio | follow-up till 7-day | The ratio of total calorie and protein intake through EN to target calorie and protein respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of new Infections | follow-up till 28-day | New infections occur after admission to ICU within 28 days after admission to this study |
| Ventilator-free days within 28 days | follow-up till 28-day | the number of days within a 28-day period that a patient does not require mechanical ventilation. |
| ICU Length of Stay | up to 24 weeks | Duration of time a patient spends in the ICU from admission to discharge. |
| ICU Mortality Rate | up to 24 weeks | The proportion of patients who die in the Intensive Care Unit (ICU) of a hospital |
| 28-Day Mortality Rate | 28 days | The proportion of patients who die within 28 days. |
| 60-Day Mortality Rate | 60 days | The proportion of patients who die within 60 days. |
| Incidence Rate of Enteral Nutrition Intolerance | 28 days | The frequency at which patients experience intolerance to enteral feeding. |
| Daily Enteral Nutrition Intake Rate | 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%. |
Countries
China
Contacts
CONTACTAiran Liu, PHD
Outcome results
None listed