NCT06059040

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

September 28, 2023

Status Verified

August 1, 2023

Enrollment Period

1 month

First QC Date

September 20, 2023

Last Update Submit

September 26, 2023

Conditions

Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • eliminating gastric residual volume monitoring on nutritional adequacy

    3 month

  • eliminating gastric residual volume monitoring on incidence of feeding intolerance indicators

    3 month

Study Arms (2)

intervention groups

ACTIVE COMPARATOR

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

control group

NO INTERVENTION

Patients in the control group will be subjected to GRV monitoring (with GRV monitoring).

Interventions

eliminating gastric residual volume monitoringPROCEDURE

eliminating gastric residual volume monitoring from routine care

intervention groups

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Yasuda H, Kondo N, Yamamoto R, Asami S, Abe T, Tsujimoto H, Tsujimoto Y, Kataoka Y. Monitoring of gastric residual volume during enteral nutrition. Cochrane Database Syst Rev. 2021 Sep 27;9(9):CD013335. doi: 10.1002/14651858.CD013335.pub2.

    PMID: 34596901BACKGROUND

  • Reignier J, Mercier E, Le Gouge A, Boulain T, Desachy A, Bellec F, Clavel M, Frat JP, Plantefeve G, Quenot JP, Lascarrou JB; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Effect of not monitoring residual gastric volume on risk of ventilator-associated pneumonia in adults receiving mechanical ventilation and early enteral feeding: a randomized controlled trial. JAMA. 2013 Jan 16;309(3):249-56. doi: 10.1001/jama.2012.196377.

    PMID: 23321763BACKGROUND

  • Wang Z, Ding W, Fang Q, Zhang L, Liu X, Tang Z. Effects of not monitoring gastric residual volume in intensive care patients: A meta-analysis. Int J Nurs Stud. 2019 Mar;91:86-93. doi: 10.1016/j.ijnurstu.2018.11.005. Epub 2019 Jan 3.

    PMID: 30677592BACKGROUND

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Enas Abdel sadek, Demonstrator

CONTACT

01093168809Enas_shoeab@nur.edu.dam.eg

Dr. Sahar Younes, Assistant Professor

CONTACT

01005551564sahar.younes.ramadan@nur.dmu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: A parallel randomized controlled design will be used in this study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2023

First Posted

September 28, 2023

Study Start

October 1, 2023

Primary Completion

November 1, 2023

Study Completion

January 1, 2024

Last Updated

September 28, 2023

Record last verified: 2023-08