Study of Impact of Not Measuring Residual Gastric Volume on Nosocomial Pneumonia Rates (NUTRIREA1)

March 17, 2026 updated by: Centre Hospitalier Departemental Vendee

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

452

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angoulême, France
        • CH Angoulème - Réanimation Polyvalente
      • La Roche-sur-Yon, France, 85000
        • CHD Vendée - service de réanimation
      • Limoges, France
        • CHU Limoges - Réanimation Polyvalente
      • Orléans, France
        • CHU Orléans - Réanimation Médicale
      • Poitiers, France
        • CHU Poitier - Réanimation Médicale
      • Tours, France
        • CHU Tours - Réanimation Polyvalente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: residual gastric volume
Procedure: monitoring of residual gastric volume
measurements of residual gastric volume every six hours in patients receiving early enteral feeding and mechanical ventilation
Other Names:
  • Residual Gastric Volume Measurement
Other: residual gastric volume not monitored
Procedure: not monitoring of residual gastric volume
no measurements of residual gastric volume
Other Names:
  • Non residual Gastric Measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare Ventilator Associated Pneumonia Rates in Patients Receiving Early Enteral Feeding Without Residual Gastric Volume (RGV) Monitoring and in Patients With RGV Monitoring
Time Frame: until weaning of mechanical ventilation (average : 14 days)
until weaning of mechanical ventilation (average : 14 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality Rate
Time Frame: 28 days
28 days
Vomiting Rates
Time Frame: until weaning of mechanical ventilation (average : 14 days)
until weaning of mechanical ventilation (average : 14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Collaborators

University Hospital, Tours

Investigators

  • Principal Investigator: Jean Reignier, MD, PhD, CHD Vendee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

June 3, 2010

First Posted (Estimated)

June 4, 2010

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD069-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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