The Effects of Different Gastric Residual Volume Thresholds for Holding Feeding in Internal Medicine.

Comparison of the Effects of Different Gastric Residual Volume Thresholds for Holding Enteral Feeding on Nutritional Intake in Critically Ill Patients in Internal Medicine

This is a randomized control trial with a parallel design. Eligible patients will be randomly assigned into two groups: a control group which will be holding tube feeding when the GRV reaches 200 mL, and an experimental group will hold tube feeding when the GRV reaches 300 mL. Enteral feeding will be administered according to the study flow chart.

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Illness
• Intervention / Treatment: Procedure: GRV thresholds

Detailed Description

Background: Malnutrition is a common issue among critically ill patients. which increases hospital stays, costs, and mortality rate. According to the study, the primary reason for nurses to hold enteral nutrition is elevated gastric residual volume (GRV). However, there is still no consensus on the definition of high residual gastric volume, there is currently no consensus among experts and scholars regarding the threshold for holding enteral nutrition. Clinical nurses may prematurely hold enteral nutrition due to concerns regarding potential side effects such as vomiting and choking. The aim of this study is to increase the threshold for holding enteral feeding based on the results of the study, in order to improve nutritional intake in critically ill patients in internal medicine.

Objective: Increase the nutritional intake of critically ill patients in the Department of Internal Medicine by increasing the threshold for holding tube feeding.

Methods: This is a randomized control trial with a parallel design. Eligible patients will be randomly assigned into two groups: a control group which will be holding tube feeding when the GRV reaches 200 mL, and an experimental group will hold tube feeding when the GRV reaches 300 mL. Enteral feeding will be administered according to the study flow chart. The outcome data will collected based on the medical chart including frequency of diet volume ratio (diet received/diet prescribed), incidence of gastrointestinal complications, ventilator days, Ventilator-associated pneumonia, length of intensive care unit(ICU) stay, changes in nutritional indicators, APACHE Ⅱ and Duration of parenteral nutrition use.

Expected result: The results of this study will provide evidence regarding the improved effectiveness and safety of increasing the threshold of GRV in medical ICU and inform future evidence-based practice.

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital
    • Contact: YUN SHAN CHOU; Email: sam573420028184@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients admitted to the internal medicine intensive care unit.
• Patients receive enteral nutrition through a nasogastric tube.
• Patients receiving continuous enteral feeding.

Exclusion Criteria:

• Patients post-abdominal surgery.
• Patients admitted to the intensive care unit due to gastrointestinal disorders (e.g., gastrointestinal bleeding, bowel obstruction).
• Patients receiving palliative care with reduced enteral nutrition.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; Hold enteral feeding when GRV reaches 200 mL(current standard)
Experimental: study group; Hold enteral feeding when GRV reaches 300 mL(current standard)	Procedure: GRV thresholds; Hold enteral feeding when GRV reaches 200 mL(current standard)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of diet volume ratio		1 day (Transfer from the Intensive Care Unit)
Incidence of gastrointestinal complications	Abdominal distension, nausea, vomiting, diarrhea, constipation	1 day (Transfer from the Intensive Care Unit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days of ventilator use		A week(Transfer from the Intensive Care Unit)
Ventilator-associated pneumonia	Diagnosis form clinical doctor according to chest x-ray	1 day (Transfer from the Intensive Care Unit)
Length of stay in the intensive care unit		A week(Transfer from the Intensive Care Unit)
Days of parenteral nutrition use		A week(Transfer from the Intensive Care Unit)
Acute Physiology and Chronic Health Evaluation score	an integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death.	1 day (Transfer from the Intensive Care Unit)
Nutrition Risk Screening 2002(NRS2002)	The NRS-2002 was developed by Kondrup et al., and is meant to be a generic tool in the hospital setting-that is, useful in detecting most of the patients who would benefit from nutritional therapy. The NRS-2002 is a simple and well-validated tool that incorporates pre-screening with four questions. If one of these is answered positively, a screening follows which includes surrogate measures of nutritional status, with static and dynamic parameters and data on the severity of the disease (stress metabolism). For each parameter, a score from 0 to 3 can result. Age over 70 years is considered a risk factor and is included in the screening tool, giving 1 point. A total score of ≥3 points means that the patient is at risk of malnutrition or already malnourished.	1 day (Transfer from the Intensive Care Unit)
Albumin in g/dL		1 day (Transfer from the Intensive Care Unit)
C-reactive protein in mg/dl		1 day (Transfer from the Intensive Care Unit)
Body mass index		1 day (Transfer from the Intensive Care Unit)

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 22, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Gastric residual volume; Enteral nutrition
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 202307181RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No