Enteral Nutrition Delivery in Prone Position Ventilated Patients With Moderate to Severe ARDS
ConditionARDS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSoutheast University, China
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
enteral nutrition through nasojejunal tube
Procedure/Surgeryplace nasojejunal tube for enteral nutrition
enteral nutrition through nasogastric tube
Procedure/Surgeryplace nasogastric tube for enteral nutrition
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Post-pyloric feeding groupExperimental treatment 1 intervention
Group B: Gastric feeding groupActive comparator 1 intervention
Trial outcomes
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.
Time frame
follow-up till 7-daySecondary outcomes
1
Incidence of new Infections
New infections occur after admission to ICU within 28 days after admission to this study
Time frame
follow-up till 28-day2
Ventilator-free days within 28 days
the number of days within a 28-day period that a patient does not require mechanical ventilation.
Time frame
follow-up till 28-day3
ICU Length of Stay
Duration of time a patient spends in the ICU from admission to discharge.
Time frame
up to 24 weeks4
ICU Mortality Rate
The proportion of patients who die in the Intensive Care Unit (ICU) of a hospital
Time frame
up to 24 weeksSponsors and contacts
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Source ClinicalTrials.gov