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

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ClinicalTrials.gov Identifier: NCT05900167
Recruitment Status : Not yet recruiting
First Posted : June 12, 2023
Last Update Posted : June 12, 2023
Sponsor:
Information provided by (Responsible Party):
Xiao Jie Chen, RenJi Hospital

Tracking Information
First Submitted Date June 2, 2023
First Posted Date June 12, 2023
Last Update Posted Date June 12, 2023
Estimated Study Start Date June 1, 2023
Estimated Primary Completion Date October 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 2, 2023)		 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Feeding Intolerance Risk Prediction Model in Patients With Enteral Nutrition Through Nasogastric Tube
Official Title Feeding Intolerance Risk Prediction Model in Patients With Enteral Nutrition Through Nasogastric Tube
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
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
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Enteral Nutrition
Intervention Behavioral: enteral nutrition
The nutritional status of the patient is assessed by the physician to determine the need for enteral nutrition
Study Groups/Cohorts enteral nutrition group
Intervention: Behavioral: enteral nutrition
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 2, 2023)		 442
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 1, 2024
Estimated Primary Completion Date October 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT05900167
Other Study ID Numbers IIT-2023-0054
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Xiao Jie Chen, RenJi Hospital
Original Responsible Party Same as current
Current Study Sponsor Xiao Jie Chen
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account RenJi Hospital
Verification Date June 2023