Effect of Eliminating Gastric Residual Volume Monitoring on Ventilator Associated Events

NCT ID: NCT06059040

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-01-01

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

Conditions

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Ventilator Associated Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A parallel randomized controlled design will be used in this study.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

eliminating gastric residual volume monitoring

Intervention Type PROCEDURE

eliminating gastric residual volume monitoring from routine care

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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eliminating gastric residual volume monitoring

eliminating gastric residual volume monitoring from routine care

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damanhour University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Enas Abdel sadek, Demonstrator

Role: CONTACT

01093168809

Dr. Sahar Younes, Assistant Professor

Role: CONTACT

01005551564

References

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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.

Reference Type BACKGROUND
PMID: 34596901 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23321763 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30677592 (View on PubMed)

Other Identifiers

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elimination GRV monitor on VAE

Identifier Type: -

Identifier Source: org_study_id

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