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

NCT05900167 | Unknown

• 1 other identifier: IIT-2023-0054
• Study Type: observational
• Target: 442
• Locations: 0 countries
• Sites: N/A

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

Conditions

Enteral Nutrition

Outcome Measures

Primary Outcomes (1)

• Feeding intolerance

  Any symptoms of gastrointestinal adverse reactions are defined as 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

Study Arms (1)

enteral nutrition group

Behavioral: enteral nutrition

Interventions

enteral nutrition BEHAVIORAL

The nutritional status of the patient is assessed by the physician to determine the need for enteral nutrition

enteral nutrition group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiao Jie Chen: lead

MeSH Terms

Interventions

Enteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 12, 2023
• Study Start: June 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share