A More Physiological Feeding Process in ICU:the Intermittent Infusion With Semi-solidification of Nutrients
Phase: NA
Conditions: Nutrition, Enteral
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Protocol 1.1 2016.11.24 
Study Title：A More Physiological Feeding Process in 
ICU:the Intermittent Infusion With Semi-solidification of 
nutrients  
 
ClinicalTrails.gov ID:      NCT 03017079      
 
Date:                  11/24/2016                  
 
Responsible party:      Man Huang         
 
Email：       huangman@zju.edu.cn            

Protocol 1.1 2016.11.24 
Study Protocol 
一. Purpose 
1） To investigate whether intermittent feeding with semi-solid nutrients improves the 
enteral nutrition complications of diarrhea, reflux and aspiration;  
2）Observe the feeding intolerance and the efficiency of the EN of critically ill patients; 
3）Observe the blood sugar and insulin secretion; 
二. Design and method 
(1)Single center, randomized, single blind, controlled prospective study; 
(2)Inclusion criteria: 
1) not less than 14 years old of critical illnesses; 
2) No long-term history of oral administration of gastrointestinal motility drugs; 
3) Nasogastric tube for enteral nutritional support treatment; 
4) No acute pulmonary infection; 
5) No previous history of upper gastrointestinal surgery; 
  (3) exclusion criteria: 
1) Refuse into the study; 
2) Stay in ICU less than 3 days 
3) acute pulmonary infection before entering the ICU; 
4)have nutritional contraindications, such as intestinal ischemia or obstruction, gastrointestinal 
hemorrhage and so on; 
5) No enteral nutrition received for less than 3 days; 
  (4) Abort criteria: 
   1) Abandoning treatment and discharge, resulting in incomplete data 
     2) EN contraindications nutrition during treatment; 
3) Other condition of researchers think that patients are not fit to continue with the study; 
  (5)Groups 
1) intermittent feeding (IF)  
2) intermittent feeding with semi-solid nutrients (IS) 
If you are assigned to the IS group, you should first receive a package of semi-solid agent to 
increase the intestinal nutrition viscosity. If you are assigned to the IF group, you will receive the 
routine nutrition treatment, and the treatment time for both groups is 3 days. After 3 days, you will 
receive routine enteral nutrition therapy. If there were serious enteral nutrition complications such 
as aspiration and abdominal distension within 3 days, the experiment would end. The treatment of 
the two groups only depends on whether semi-solid agent was added, while the rest of the 
treatment measures were consistent. 
  (6)Test 
 Blood (Microvascular blood sugar+ C-peptide release test), Secretions from the posterior 
pharynx and trachea; 
三. Study process 

Protocol 1.1 2016.11.24 
四. How to protect high-risk groups or vulnerable groups 
The subject of this study is critically illnesses. Before entering the research group, the 
researchers must obtain the informed consent by the patient or the agent authorizer about the 
specific content of the study. For details, please refer to the informed consent. 
五. Sample Size Calculating 
 According to the literature reported, the incidence of gastrointestinal intolerance (FI) is about 
30.8%. We presume that δ =-0.05, α=0.025, β=0.20, the non-inferior efficiency test design is 
adopted and the formula is applied: 
. 
六. Data management and confidentiality 
Data entry and management were designed in the form of a case report. A case report is a 
document designed according to the protocol for recording the data of each subject during the 

Protocol 1.1 2016.11.24 
trial. 
All records relating to the subject's identity shall be kept confidential and shall not be made 
public to the extent permitted by applicable laws and/or regulations. 
七. Informed consent 
The subject of this study is critically illnesses. Before entering the research group, the 
researchers must obtain the informed consent by the patient or the agent authorizer about the 
specific content of the study. For details, please refer to the informed consent. The specific 
procedures for obtaining informed consent include oral and written informed consent from the 
physician to the patient, patient's family or authorized agent for the above study. The patient 
volunteered to participate in the study. Patients understand that they can withdraw from the study 
at any time for no reason, without affecting their future treatment. At the same time, the patient or 
the agent authorizer will obtain a copy of this informed consent. At the same time, the subjects 
included in this study were critically illnesses, and the subjects, told and signed, were mainly 
immediate family members. 
八. Report of adverse events 
After entering this study, there were some possible adverse reactions: 
(1) Diarrhea, which is most popular, may cause water and electrolyte disturbance in severe 
cases;  
(2) Nausea and vomiting, and stomach retention; 
(3) High and low blood sugar;  
(4) Aspiration is one of the more serious complications. Patients with weakness, old age or 
coma are more likely to have liquid diet reflux, especially those with esophageal reflux. 
 (5)Take off and plug the pipe. 
Patients will not receive additional treatment or take additional risks for participating in the 
study