An Early Enteral Nutrition Protocol in Shanghai

Study Overview
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Brief Summary
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compare different enteral nutrition strategy in patients with mechanical ventilation

Detailed Description
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There has been many evidence that deficiency in energy and protein take-in are associated with poor outcome in critical patients. To reach an adequate amount of energy and protein is critical in patients with respiratory failure and with mechanical ventilation, as it prevents muscle dystrophy and thus prevents ICU acquired weakness, leading to a better outcome in the end. Enteral Nutrition is preferred as it prevents gut dysfunction in respiratory failure patients, and may prevent further infection. But there are many challenge in implement a good enteral nutrition therapy, and energy or protein deficiency is common in patient with respiratory failure. There have been many protocols aiming at reaching enough enteral nutrition for ICU patients, most of which are based on a background of western and developed countries. The investigators developped a enteral nutrition protocol based on an unique cultural background of eastern developing country, trying to help the ICU patients reaching nutrition target, so that the patients may have better outcome.

Official Title
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The Shanghai Protocol for Early Enteral Nutrition in Mechanical Ventilated Patients

Conditions
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Critical Illness, Enteral Feeding Intolerance

Intervention / Treatment
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* Other: Standard care
* Other: Protocol care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICU patients Receiving mechanical ventilation (MV) both Non-invasive ventilation and invasive ventilation Expecting MV more than 72 hours Exclusion Criteria: Pregnancy ICU stay < 72hr

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard care<br>Standard care: patients receive enteral nutrition in accordance with the usual practice in the participating units | Other: Standard care<br>* Standard care: patients receive enteral nutrition in accordance with the usual practice in the participating units<br>|
| Experimental: Protocol care<br>Protocol care： patient receive enteral nutrition in accordance with enteral nutrition protocol studied | Other: Protocol care<br>* Protocol care： patient receive enteral nutrition in accordance with enteral nutrition protocol studied<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| energy target fulfilling rate | the proportion of patients in both arms meeting the targeted energy in-take | 7 days from enrollment | 
| protein target fulfilling rate | the proportion of patients in both arms meeting the targeted protein in-take | 7 days from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | mortality | 28 days from enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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feeding protocol