Study of Impact of Not Measuring Residual Gastric Volume on Nosocomial Pneumonia Rates (NUTRIREA1)
Primary Purpose
Ventilation-Associated Pneumonia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
monitoring of residual gastric volume
not monitoring of residual gastric volume
Sponsored by
About this trial
This is an interventional prevention trial for Ventilation-Associated Pneumonia focused on measuring mechanical ventilation, enteral nutrition, Ventilation-Associated Pneumonia, residual gastric volume measurement, vomiting, gastro-oesophageal reflux, early enteral nutrition, Intensive care unit, Enteral Feeding
Eligibility 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.
Sites / Locations
- CH Angoulème - Réanimation Polyvalente
- CHD Vendée - Service de Réanimation
- CHU Limoges - Réanimation Polyvalente
- CHU Orléans - Réanimation Médicale
- CHU Poitier - Réanimation Médicale
- CHU Tours - Réanimation Polyvalente
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
residual gastric volume
residual gastric volume not monitored
Arm Description
Outcomes
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
Secondary Outcome Measures
mortality rate
vomiting rates
Full Information
NCT ID
NCT01137487
First Posted
May 19, 2010
Last Updated
February 28, 2013
Sponsor
Centre Hospitalier Departemental Vendee
Collaborators
University Hospital, Tours
1. Study Identification
Unique Protocol Identification Number
NCT01137487
Brief Title
Study of Impact of Not Measuring Residual Gastric Volume on Nosocomial Pneumonia Rates
Acronym
NUTRIREA1
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee
Collaborators
University Hospital, Tours
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
452 (Actual)
8. Arms, Groups, and Interventions
Arm Title
residual gastric volume
Arm Type
Other
Arm Title
residual gastric volume not monitored
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
monitoring of residual gastric volume
Other Intervention Name(s)
Residual Gastric Volume Measurement
Intervention Description
measurements of residual gastric volume every six hours in patients receiving early enteral feeding and mechanical ventilation
Intervention Type
Procedure
Intervention Name(s)
not monitoring of residual gastric volume
Other Intervention Name(s)
Non residual Gastric Measurement
Intervention Description
no measurements of residual gastric volume
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
mortality rate
Time Frame
60 days
Title
vomiting rates
Time Frame
until weaning of mechanical ventilation (average : 14 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean REIGNIER, MD, PhD
Organizational Affiliation
CHD Vendée
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Angoulème - Réanimation Polyvalente
City
Angouleme
Country
France
Facility Name
CHD Vendée - Service de Réanimation
City
La Roche sur Yon
ZIP/Postal Code
85000
Country
France
Facility Name
CHU Limoges - Réanimation Polyvalente
City
Limoges
Country
France
Facility Name
CHU Orléans - Réanimation Médicale
City
Orleans
Country
France
Facility Name
CHU Poitier - Réanimation Médicale
City
Poitiers
Country
France
Facility Name
CHU Tours - Réanimation Polyvalente
City
Tours
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
23321763
Citation
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.
Results Reference
derived
Learn more about this trial
Study of Impact of Not Measuring Residual Gastric Volume on Nosocomial Pneumonia Rates
We'll reach out to this number within 24 hrs