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
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Condition or disease | Intervention/treatment |
---|---|
Enteral Nutrition | Behavioral: enteral nutrition |
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 |
- 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
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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 |
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
Responsible Party: | Xiao Jie Chen, Nurse, RenJi Hospital |
ClinicalTrials.gov 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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |