Effect of Eliminating Gastric Residual Volume Monitoring on Ventilator Associated Events

Ventilator Associated Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06059040
• Other study ID #: elimination GRV monitor on VAE
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: August 2023
• Source: Damanhour University
• Contact: Enas Abdel sadek, Demonstrator
• Phone: 01093168809
• Email: Enas_shoeab[@]nur.edu.dam.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: January 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Procedure:
• eliminating gastric residual volume monitoring
eliminating gastric residual volume monitoring from routine care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour University

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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