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Feeding Intolerance Risk Prediction Model in Patients With Enteral Nutrition Through Nasogastric Tube

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05900167
Recruitment Status : Not yet recruiting
First Posted : June 12, 2023
Last Update Posted : June 12, 2023
Information provided by (Responsible Party):
Xiao Jie Chen, RenJi Hospital

Brief Summary:
To explore the risk factors of enteral feeding intolerance in critically ill patients, build a risk prediction model and verify it, in order to provide reference for early identification and screening of high-risk groups

Condition or disease Intervention/treatment
Enteral Nutrition Behavioral: enteral nutrition

Detailed Description:
Based on the previous literature study, the risk factors of enteral feeding intolerance in critically ill patients were obtained, and the general demographic, disease and treatment information of patients were collected. Four machine learning algorithms, namely traditional logistic regression, random forest, support vector machine and naive Bayes, were used to construct risk prediction models, and the optimal model was selected and verified by comparing the model performance

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Study Type : Observational
Estimated Enrollment : 442 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Feeding Intolerance Risk Prediction Model in Patients With Enteral Nutrition Through Nasogastric Tube
Estimated Study Start Date : June 1, 2023
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2024

Group/Cohort Intervention/treatment
enteral nutrition group Behavioral: enteral nutrition
The nutritional status of the patient is assessed by the physician to determine the need for enteral nutrition

Primary Outcome Measures :
  1. Feeding intolerance [ Time Frame: Follow-up was considered complete when the patient reached 7 days of enteral nutrition, the patient was transferred from the ICU, or the patient experienced nutritional interruption for other reasons ]
    Any symptoms of gastrointestinal adverse reactions are defined as feeding intolerance

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The sample size calculation method of this study was based on the results of previous literature studies to obtain enteral nutritional feeding intolerance According to the sample size estimation method of N= [(risk variable) ×(5 ~ 10)]

,the incidence of feeding intolerance was 41.3%,so at least 269 samples are needed for further examination.Considering a 10% loss of follow-up rate, the estimated sample size is 299 cases, the data collected in this part of the study as the model Develop the data set.Using the ratio of modeling group: test group = 7:3, and considering 10% loss of follow-up rate, the minimum sample of test group was 143 cases. Therefore, a total of at least 442 samples are needed in this study.


Inclusion Criteria:

  • The nutritional status of the patient is assessed by the doctor and the need for enteral nutrition is determined;Patients with first nasogastric tube insertion and successful enteral feeding;There was no gastrointestinal discomfort before enteral nutrition;Patients (or family members) authorized to participate in this study and signed informed consent

Exclusion Criteria:

  • Previous gastrointestinal disease or gastrointestinal surgery;enteral nutrition through gastrostomy tube or jejunostomy tube;discontinuation or suspension of enteral nutrition for special reasons other than feeding intolerance;Patients with serious lack of clinical data
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Responsible Party: Xiao Jie Chen, Nurse, RenJi Hospital Identifier: NCT05900167    
Other Study ID Numbers: IIT-2023-0054
First Posted: June 12, 2023    Key Record Dates
Last Update Posted: June 12, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No