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

• Sponsor: Xiao Jie Chen (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05900167
• Collaborator: (none)
• Enrollment: 442
• Anticipated Duration (Months): 16

Study Details

Study Description

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	Phase
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

Study Design

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

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Feeding intolerance [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Xiao Jie Chen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiao Jie Chen, Nurse, RenJi Hospital
• ClinicalTrials.gov Identifier: NCT05900167
• Other Study ID Numbers: IIT-2023-0054
• First Posted: Jun 12, 2023
• Last Update Posted: Jun 12, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 12, 2023