Effect of Eliminating Gastric Residual Volume Monitoring on Ventilator Associated Events

Sponsor
Damanhour University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06059040
Collaborator
(none)
160
2
3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: eliminating gastric residual volume monitoring
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A parallel randomized controlled design will be used in this study.A parallel randomized controlled design will be used in this study.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effect of Eliminating Routine Gastric Residual Volume Monitoring on Ventilator-associated Events in Patients Receiving Enteral Feeding
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. eliminating gastric residual volume monitoring on ventilator associated events [3 month]

    use centers for disease control and prevention (CDC) calculators for evaluating VAE version 9.0 2021

Secondary Outcome Measures

  1. eliminating gastric residual volume monitoring on nutritional adequacy [3 month]

    evaluation daily caloric requirement by body mass index that calculated using the equation (Weight in kg /height in cm) 2

  2. eliminating gastric residual volume monitoring on incidence of feeding intolerance indicators [3 month]

    evaluation of abdominal circumference, abdominal distension, bowel sounds, the episodes of vomiting and diarrhea

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adults (agedā‰„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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Damanhour University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Damanhour University
ClinicalTrials.gov Identifier:
NCT06059040
Other Study ID Numbers:
  • elimination GRV monitor on VAE
First Posted:
Sep 28, 2023
Last Update Posted:
Sep 28, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2023