Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

May 19, 2010
February 28, 2013
May 2010
June 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01137487 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Ventilation-Associated Pneumonia
  • 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
  • Procedure: not monitoring of residual gastric volume
    no measurements of residual gastric volume
    Other Name: Non residual Gastric Measurement
  • residual gastric volume
    Intervention: Procedure: monitoring of residual gastric volume
  • residual gastric volume not monitored
    Intervention: Procedure: not monitoring of residual gastric volume
Reignier J, Mercier E, Le Gouge A, Boulain T, Desachy A, Bellec F, Clavel M, Frat JP, Plantefeve G, Quenot JP, Lascarrou JB; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Effect of not monitoring residual gastric volume on risk of ventilator-associated pneumonia in adults receiving mechanical ventilation and early enteral feeding: a randomized controlled trial. JAMA. 2013 Jan 16;309(3):249-56. doi: 10.1001/jama.2012.196377.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
452
August 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01137487
NUTRIREA1
Yes
Centre Hospitalier Departemental Vendee
Centre Hospitalier Departemental Vendee
University Hospital, Tours
Principal Investigator: Jean REIGNIER, MD, PhD CHD Vendée
Centre Hospitalier Departemental Vendee
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP