Effect of Eliminating Gastric Residual Volume Monitoring on Ventilator Associated Events

Study Overview
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Brief Summary
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The aims of this study are to investigate the effect of eliminating routine GRV monitoring on VAEs in patients receiving MV and early EF, Determine the effect of eliminating routine GRV monitoring on nutritional adequacy in patients receiving MV and early EF and evaluate the effect of eliminating routine GRV monitoring on feeding intolerance in patients receiving enteral feeding.

Detailed Description
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Early enteral nutrition (EN) is consistently recommended as first line nutrition therapy in critically ill patients since it favorably alters outcome, providing both nutrition and non-nutrition benefits. However, critically ill patients receiving mechanical ventilation (MV) are at risk for regurgitation, pulmonary aspiration, and eventually ventilator-associated pneumonia (VAP). EN may increase these risks when gastrointestinal (GI) dysfunction is present. Gastric residual volume (GRV) is considered a surrogate parameter of GI dysfunction during the progression of enteral feeding in the early phase of critical illness and beyond. About 62% of critically ill patients receive enteral nutrition (EN) and in patients on MV, enteral feeding was connected to a threefold increase in the development of VAP. A new surveillance definition of ventilator-associated events (VAE) was introduced by the National Healthcare Safety Network (NHSN) in 2013 to identify patients who develop complications of MV. It outlines the various events in a step-by-step fashion, beginning with ventilator-associated complications (VAC), moving on to infectious complications (IVAC), and finally VAP. According to the NHSN, VAEs occur within 9% to 40% of mechanically ventilated patients

Official Title
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Effect of Eliminating Routine Gastric Residual Volume Monitoring on Ventilator-associated Events in Patients Receiving Enteral Feeding

Conditions
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Ventilator Associated Pneumonia

Intervention / Treatment
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* Procedure: eliminating gastric residual volume monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (aged≥18 years) Newly admitted mechanically ventilated patients who are attached to a mechanical ventilator for at least 48 hours. Starting enteral nutrition via a nasogastric tube within 36 hours after intubation. Exclusion Criteria: Abdominal surgery within the past month. History of esophageal, duodenal, pancreatic, or gastric surgery. Bleeding from the esophagus, stomach, or bowel. Enteral nutrition via a jejunostomy or gastrostomy. Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A parallel randomized controlled design will be used in this study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intervention groups<br>Patients in the intervention group will not be monitored for GRV (no GRV monitoring) and will be evaluated for the presence of feeding intolerance indicators such as vomiting, regurgitation, and abdominal distention. | Procedure: eliminating gastric residual volume monitoring<br>* eliminating gastric residual volume monitoring from routine care<br>|
| No Intervention: control group<br>Patients in the control group will be subjected to GRV monitoring (with GRV monitoring). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eliminating gastric residual volume monitoring on ventilator associated events | use centers for disease control and prevention (CDC) calculators for evaluating VAE version 9.0 2021 | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eliminating gastric residual volume monitoring on nutritional adequacy | evaluation daily caloric requirement by body mass index that calculated using the equation (Weight in kg /height in cm) 2 | 3 month | 
| eliminating gastric residual volume monitoring on incidence of feeding intolerance indicators | evaluation of abdominal circumference, abdominal distension, bowel sounds, the episodes of vomiting and diarrhea | 3 month |