Clinical trial NCT06059040: Effect of Eliminating Gastric Residual Volume Monitoring on Ventilator Associated Events
Official title: Effect of Eliminating Routine Gastric Residual Volume Monitoring on Ventilator-associated Events in Patients Receiving Enteral Feeding
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ventilator Associated Pneumonia
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel randomized controlled design will be used in this study.
Primary purpose: BASIC_SCIENCE

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: eliminating gastric residual volume monitoring on ventilator associated events
timeFrame: 3 month
Secondary outcomes:
measure: eliminating gastric residual volume monitoring on nutritional adequacy
timeFrame: 3 month
measure: eliminating gastric residual volume monitoring on incidence of feeding intolerance indicators
timeFrame: 3 month
Other outcomes:
Locations:
Study officials:
References:
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.
citation: 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.
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.