The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care (ENTERIC) Study

Study Overview
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Brief Summary
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This is a multi-centre randomised controlled trial comparing early jejunal feeding (using a frictional nasojejunal [NJ] tube) and standard feeding in critical illness.

Official Title
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The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care Study

Conditions
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Critical Illness, Malabsorption Syndromes

Intervention / Treatment
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* Procedure: Early jejunal feeding (using frictional NJ tube)
* Procedure: Standard feeding (using nasogastric [NG] tube)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICU patients are eligible for enrolment if they meet all of the following: Age > 18 years old In ICU for < 48 hours prior to enrolment Receiving invasive mechanical ventilation (through an endotracheal tube or tracheostomy, but NOT a facemask) with an anticipated need for > 48 hours of mechanical ventilation Receiving a continuous infusion of any one of: morphine > 2 mg/hour, fentanyl > 20 mcg/hour, or pethidine > 20 mg/hour Either a single GRV > 150 mls (whilst receiving EN via a NG tube) or nasogastric drainage > 500 mls over 12 hours (whether receiving EN or not) Exclusion Criteria: Patients will be ineligible for enrolment if they meet any of the following: Previous or recent surgery which has altered the anatomy of the upper gastrointestinal tract (eg. oesophagectomy, gastrectomy, any gastric anastomosis surgery, gastroplasty, pyloroplasty, pancreaticoduodenectomy [Whipple's procedure]) Known gastric malignancy Known oesophageal varices Current admission for peptic ulceration Current mechanical bowel obstruction Current gastrostomy, jejunostomy, or surgically-placed enteral tube in situ Contraindication to the use of the nose and mouth for enteral tube insertion (eg. recent facial trauma or surgery) Receiving nutritional support prior to ICU admission Severe coagulopathy (defined by platelet count < 20 and/or international normalized ratio [INR] > 4.0)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Early jejunal feeding (using frictional NJ tube)|nan|
|Procedure: Standard feeding (using nasogastric [NG] tube)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of EN delivered during the Intensive Care Unit (ICU) stay |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of EN delivered during the first 10 days of the study |  |  | 
| Daily cumulative proportion of EN delivered |  |  | 
| Ventilator-associated pneumonia rate |  |  | 
| Duration of mechanical ventilation |  |  | 
| Duration of hospitalisation |  |  | 
| Mortality at hospital discharge |  |  | 
| Success rate of placement into both the small bowel, generally, and the jejunum, specifically |  |  | 
| Complication rates (as compared to the nasogastric tube) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanically-ventilated, medical-surgical critically ill patients, reduced gastric motility