Clinical Trials Directory

Trials / Completed

CompletedNCT01137487

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
452 (actual)
Sponsor
Centre Hospitalier Departemental Vendee · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREmonitoring of residual gastric volumemeasurements of residual gastric volume every six hours in patients receiving early enteral feeding and mechanical ventilation
PROCEDUREnot monitoring of residual gastric volumeno measurements of residual gastric volume

Timeline

Start date
2010-05-01
Primary completion
2011-06-01
Completion
2011-08-01
First posted
2010-06-04
Last updated
2026-04-06
Results posted
2026-04-06

Locations

6 sites across 1 country: France

Source: ClinicalTrials.gov record NCT01137487. Inclusion in this directory is not an endorsement.