Study of Impact of Not Measuring Residual Gastric Volume on Nosocomial Pneumonia Rates

Study Overview
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Brief Summary
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Early enteral feeding is a key component of the management of critically ill patients receiving mechanical ventilation. However, enteral feeding has been associated with serious complications such as aspiration followed by ventilator-associated pneumonia (VAP). Many critically ill patients experience poor tolerance of early enteral nutrition because of impaired gastric motility, which leads to a sequence of delayed gastric emptying, increased gastric volume, gastroesophageal reflux, vomiting, aspiration, and VAP. Routine monitoring of residual gastric volume (RGV) to minimize the risk of aspiration is standard practice. RGV is assumed to reflect gastric content, with high RGVs indicating impaired gastric emptying that requires discontinuation of enteral feeding in order to prevent aspiration.However, RGV measurement is neither standardized nor validated. The cut-off value that may indicate an increased risk of aspiration and therefore a need for discontinuing enteral feeding has not been determined, and cut-offs used in studies have ranged from 150 to 500 ml. No data are available to support a correlation between RGV and the rates of adverse events. In experimental studies, RGV failed to correlate with vomiting, aspiration, or VAP. The investigators hypothesize that RGV monitoring fails to decrease the risk of VAP and leed to inappropriate interruptions in enteral feeding with a risk of underfeeding. To assess the effects of not measuring RGV on VAP and enteral feeding delivery, the investigators designed a prospective randomized controlled study.

Official Title
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Impact of Not Measuring Residual Gastric Volume on Nosocomial Pneumonia Rates in Mechanically Ventilated Patients Receiving Early Enteral Feeding: a Randomized-controlled Study

Conditions
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Ventilation-Associated Pneumonia

Intervention / Treatment
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* Procedure: monitoring of residual gastric volume
* Procedure: not monitoring of residual gastric volume


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treatment with invasive mechanical ventilation Feeding via nasogastric tube within 36 hours after the initiation of endotracheal mechanical ventilation. Age over 18 years Informed consent Exclusion Criteria: Mechanical ventilation started more than 36 hours before institution of enteral feeding Patients turned in the prone position at inclusion Abdominal surgery within 1 month before inclusion History of esophageal or gastric surgery EN via a gastrostomy or a jejunostomy Bleeding from esophagus, stomach or bowel Moribund patient Age less than 18 years Pregnancy. No informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: residual gastric volume<br> | Procedure: monitoring of residual gastric volume<br>* measurements of residual gastric volume every six hours in patients receiving early enteral feeding and mechanical ventilation<br>* Other names: Residual Gastric Volume Measurement;|
| Other: residual gastric volume not monitored<br> | Procedure: not monitoring of residual gastric volume<br>* no measurements of residual gastric volume<br>* Other names: Non residual Gastric Measurement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare ventilator associated pneumonia rates in patients receiving early enteral feeding without residual gastric volume (RGV) monitoring and in patients with RGV monitoring |  | until weaning of mechanical ventilation (average : 14 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality rate |  | 60 days | 
| vomiting rates |  | until weaning of mechanical ventilation (average : 14 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical ventilation, enteral nutrition, Ventilation-Associated Pneumonia, residual gastric volume measurement, vomiting, gastro-oesophageal reflux, early enteral nutrition, Intensive care unit, Enteral Feeding