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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01137487
Acronym
NUTRIREA1
Enrollment
452
Registered
2010-06-04
Start date
2010-05-01
Completion date
2011-08-01
Last updated
2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilation-Associated Pneumonia

Keywords

mechanical ventilation, enteral nutrition, Ventilation-Associated Pneumonia, residual gastric volume measurement, vomiting, gastro-oesophageal reflux, early enteral nutrition, Intensive care unit, Enteral Feeding

Brief 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.

Interventions

PROCEDUREmonitoring of residual gastric volume

measurements of residual gastric volume every six hours in patients receiving early enteral feeding and mechanical ventilation

PROCEDUREnot monitoring of residual gastric volume

no measurements of residual gastric volume

Sponsors

Centre Hospitalier Departemental Vendee
Lead SponsorOTHER
University Hospital, Tours
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Compare Ventilator Associated Pneumonia Rates in Patients Receiving Early Enteral Feeding Without Residual Gastric Volume (RGV) Monitoring and in Patients With RGV Monitoringuntil weaning of mechanical ventilation (average : 14 days)

Secondary

MeasureTime frame
Mortality Rate28 days
Vomiting Ratesuntil weaning of mechanical ventilation (average : 14 days)

Countries

France

Contacts

PRINCIPAL_INVESTIGATORJean REIGNIER, MD, PhD

CHD Vendée

Baseline characteristics

Characteristic
Age, Continuous62 years
STANDARD_DEVIATION 14
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
France
227 Participants
Sex: Female, Male
Female
134 Participants
Sex: Female, Male
Male
156 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
other
Total, other adverse events
0 / 2220 / 227
serious
Total, serious adverse events
0 / 2220 / 227

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026