Effect of Eliminating Gastric Residual Volume Monitoring on Ventilator Associated Events

September 26, 2023 updated by: Damanhour University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intervention groups
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
eliminating gastric residual volume monitoring from routine care
No Intervention: control group
Patients in the control group will be subjected to GRV monitoring (with GRV monitoring).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
eliminating gastric residual volume monitoring on ventilator associated events
Time Frame: 3 month
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
Time Frame: 3 month
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
Time Frame: 3 month
evaluation of abdominal circumference, abdominal distension, bowel sounds, the episodes of vomiting and diarrhea
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • elimination GRV monitor on VAE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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