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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06113393
Enrollment
230
Registered
2023-11-02
Start date
2024-01-31
Completion date
2024-12-31
Last updated
2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

Enteral nutrition, Gastric residual volume

Brief summary

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.

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.

Interventions

PROCEDUREGRV thresholds

Hold enteral feeding when GRV reaches 200 mL(current standard)

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Frequency of diet volume ratio1 day (Transfer from the Intensive Care Unit)
Incidence of gastrointestinal complications1 day (Transfer from the Intensive Care Unit)Abdominal distension, nausea, vomiting, diarrhea, constipation

Secondary

MeasureTime frameDescription
Days of ventilator useA week(Transfer from the Intensive Care Unit)
Ventilator-associated pneumonia1 day (Transfer from the Intensive Care Unit)Diagnosis form clinical doctor according to chest x-ray
Length of stay in the intensive care unitA week(Transfer from the Intensive Care Unit)
Body mass index1 day (Transfer from the Intensive Care Unit)
Acute Physiology and Chronic Health Evaluation score1 day (Transfer from the Intensive Care Unit)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.
Nutrition Risk Screening 2002(NRS2002)1 day (Transfer from the Intensive Care Unit)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.
Albumin in g/dL1 day (Transfer from the Intensive Care Unit)
Days of parenteral nutrition useA week(Transfer from the Intensive Care Unit)
C-reactive protein in mg/dl1 day (Transfer from the Intensive Care Unit)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026