The Effect of Early Enteral Nutrition Feeding Process Assisted by Gastrointestinal Ultrasonography

Study Overview
=================
Brief Summary
-----------------
In critical ill patients, feeding protocol is one of the important factor which determines the successful implementation of enteral nutrition（EN）. Acute gastrointestinal injury(AGI) affects feeding tolerance, which greatly determines the successful implementation of feeding protocol. In our previously study, we found that transabdominal intestinal sonography is helpful to diagnosis AGI. Thus in this study ,we apply transabdominal gastrointestinal sonography to feeding protocol, to assess the feasibility of gastrointestinal sonography assisted enteral nutrition and its impact on critical ill patients.

Detailed Description
-----------------
Patients meeting inclusion and exclusion criteria were randomly assigned to the intervention group and control group. During the first week of initiation of nutrition, enteral nutrition was conducted according to different procedures to observe the impact of different feeding procedures on clinical indicators

Official Title
-----------------
The Effect of Early Enteral Nutrition Feeding Process Assisted by Gastrointestinal Ultrasonography in Critically Ill Patients

Conditions
-----------------
Critical Illness, Acute Gastrointestinal Injury

Intervention / Treatment
-----------------
* Other: Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The age is not less than 18 years within 24 hours after entering ICU Acute Physiology and Chronic Health Evaluation II (APACHE II) score > 8 the estimated length of stay in ICU is more than 3 days informed consent Exclusion Criteria: The normal anatomy of stomach, small intestine or the right colon was significantly changed (Gastrectomy, esophagectomy, pancreaticoduodenectomy, gastrointestinal bypass surgery, the presence of short bowel syndrome,etc.) Uncontrolled gastrointestinal bleeding Uncontrolled intestinal obstruction Uncontrolled mesenteric vascular disease Pregnancy breastfeeding Received enteral nutrition or parenteral nutrition within 24 hours prior to ICU admission Predict death within 48 hours after ICU admission Enrolled in this study before.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Implement nutrition therapy according to existing feeding procedures | |
| Experimental: intervention group<br>Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound | Other: Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound<br>* Once the critical ill patients is stable, enteral nutrition was initiated following a procedure assisted by gastrointestinal ultrasound.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | Day28 after enrollment | 
| mortality |  | Day60 after enrollment | 
| mortality |  | Day90 after enrollment | 
| Enteral nutrition support days |  | within first seven days after enteral nutrition initiation | 
| Target-reaching rate through enteral route | percentage of participants who reach target calorie through enteral route | within first seven days after enteral nutrition initiation | 
| The application rate of parenteral nutrition（PN） | percentage of participants who needs parenteral nutrition | within first seven days after enteral nutrition initiation | 
| The application rate of prokinetic drugs | percentage of participants who needs prokinetic drugs | within first seven days after enteral nutrition initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sequential Organ Failure Assessment score | The value ranges from 0 to 24. A higher score means a worse outcome. | The first day after enrollment. | 
| Acute Physiology and Chronic Health Evaluation score | The value ranges from 0 to 71. A higher score means a worse outcome. | The first day after enrollment | 
| The average dose of vasoactive drugs |  | First week of the study | 
| Days of vasoactive drugs |  | Through study completion, an average of 1 year | 
| Days of mechanical ventilation |  | Through study completion, an average of 1 year | 
| Days of continuous renal replacement |  | Through study completion, an average of 1 year | 
| Serum prealbumin in milligram/liter |  | Day7 after enteral nutrition initiation | 
| Serum prealbumin in milligram/liter |  | Day14 after enteral nutrition initiation | 
| Serum transferrin in milligram/liter |  | Day7 after enteral nutrition initiation | 
| Serum transferrin in milligram/liter |  | Day14 after enteral nutrition initiation | 
| The thickness of diaphragm under ultrasonography in centimeter |  | Day7 after enteral nutrition initiation | 
| The thickness of diaphragm under ultrasonography in centimeter |  | Day14 after enteral nutrition initiation | 
| The thickness of diaphragm under ultrasonography in centimeter |  | Day28 after enteral nutrition initiation | 
| The thickness of quadriceps under ultrasonography in centimeter |  | Day7 after enteral nutrition initiation | 
| The thickness of quadriceps under ultrasonography in centimeter |  | Day14 after enteral nutrition initiation | 
| The thickness of quadriceps under ultrasonography in centimeter |  | Day28 after enteral nutrition initiation | 
| The strength of upper limb according to the Lovett muscle strength scale | The value ranges from 0 to 5. A higher score means a better outcome. | Day7 after enteral nutrition initiation | 
| The strength of upper limb according to the Lovett muscle strength scale | The value ranges from 0 to 5. A higher score means a better outcome. | Day14 after enteral nutrition initiation | 
| The strength of upper limb according to the Lovett muscle strength scale | The value ranges from 0 to 5. A higher score means a better outcome. | Day28 after enteral nutrition initiation | 
| The strength of upper limb according to the Lovett muscle strength scale | The value ranges from 0 to 5. A higher score means a better outcome. | Through study completion, an average of 1 year. | 
| The mid-arm circumference in centimeter |  | Day7 after enteral nutrition initiation | 
| The mid-arm circumference in centimeter |  | Day14 after enteral nutrition initiation | 
| The mid-arm circumference in centimeter |  | Day28 after enteral nutrition initiation | 
| The mid-arm circumference in centimeter |  | Through study completion, an average of 1 year. | 
| The Medical Research Council sum score | The value ranges from 0 to 60. A higher score means a better outcome. | Day14 after enteral nutrition initiation | 
| The Medical Research Council sum score | The value ranges from 0 to 60. A higher score means a better outcome. | Day28 after enteral nutrition initiation | 
| The Medical Research Council sum score | The value ranges from 0 to 60. A higher score means a better outcome. | Through study completion, an average of 1 year |