Clinical trial NCT06113393: The Effects of Different Gastric Residual Volume Thresholds for Holding Feeding in Internal Medicine.
Official title: Comparison of the Effects of Different Gastric Residual Volume Thresholds for Holding Enteral Feeding on Nutritional Intake in Critically Ill Patients in Internal Medicine
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Critical Illness
Keywords: Enteral nutrition
Gastric residual volume
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of diet volume ratio
timeFrame: 1 day (Transfer from the Intensive Care Unit)
measure: Incidence of gastrointestinal complications
timeFrame: 1 day (Transfer from the Intensive Care Unit)
Secondary outcomes:
measure: Days of ventilator use
timeFrame: A week(Transfer from the Intensive Care Unit)
measure: Ventilator-associated pneumonia
timeFrame: 1 day (Transfer from the Intensive Care Unit)
measure: Length of stay in the intensive care unit
timeFrame: A week(Transfer from the Intensive Care Unit)
measure: Days of parenteral nutrition use
timeFrame: A week(Transfer from the Intensive Care Unit)
measure: Acute Physiology and Chronic Health Evaluation score
timeFrame: 1 day (Transfer from the Intensive Care Unit)
measure: Nutrition Risk Screening 2002(NRS2002)
timeFrame: 1 day (Transfer from the Intensive Care Unit)
measure: Albumin in g/dL
timeFrame: 1 day (Transfer from the Intensive Care Unit)
measure: C-reactive protein in mg/dl
timeFrame: 1 day (Transfer from the Intensive Care Unit)
measure: Body mass index
timeFrame: 1 day (Transfer from the Intensive Care Unit)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: