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

This study has been completed.
Sponsor:
Collaborator:
University Hospital, Tours
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier:
NCT01137487
First received: May 19, 2010
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Ventilation-Associated Pneumonia
Procedure: monitoring of residual gastric volume
Procedure: not monitoring of residual gastric volume

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact of Not Measuring Residual Gastric Volume on Nosocomial Pneumonia Rates in Mechanically Ventilated Patients Receiving Early Enteral Feeding: a Randomized-controlled Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Departemental Vendee:

Primary Outcome Measures:
  • To 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • mortality rate [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • vomiting rates [ Time Frame: until weaning of mechanical ventilation (average : 14 days) ] [ Designated as safety issue: No ]

Enrollment: 452
Study Start Date: May 2010
Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Residual Gastric Volume Measurement
residual gastric volume not monitored Procedure: not monitoring of residual gastric volume
no measurements of residual gastric volume
Other Name: Non residual Gastric Measurement

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01137487

Locations
France
CH Angoulème - Réanimation Polyvalente
Angouleme, France
CHD Vendée - Service de Réanimation
La Roche sur Yon, France, 85000
CHU Limoges - Réanimation Polyvalente
Limoges, France
CHU Orléans - Réanimation Médicale
Orleans, France
CHU Poitier - Réanimation Médicale
Poitiers, France
CHU Tours - Réanimation Polyvalente
Tours, France
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
University Hospital, Tours
Investigators
Principal Investigator: Jean REIGNIER, MD, PhD CHD Vendée
  More Information

No publications provided by Centre Hospitalier Departemental Vendee

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT01137487     History of Changes
Other Study ID Numbers: NUTRIREA1
Study First Received: May 19, 2010
Last Updated: February 28, 2013
Health Authority: France: Institutional Ethical Committee
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Departemental Vendee:
mechanical ventilation
enteral nutrition
Ventilation-Associated Pneumonia
residual gastric volume measurement
vomiting
gastro-oesophageal reflux
early enteral nutrition
Intensive care unit
Enteral Feeding

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 23, 2014