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

Ventilation-Associated Pneumonia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137487
• Other study ID #: NUTRIREA1
• Status: Completed
• Phase: N/A
• First received: May 19, 2010
• Last updated: February 28, 2013
• Start date: May 2010
• Est. completion date: August 2011

Study information

• Verified date: February 2013
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical CommitteeFrance: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: August 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumonia
• Ventilation-Associated Pneumonia

Intervention

Procedure:
• monitoring of residual gastric volume
measurements of residual gastric volume every six hours in patients receiving early enteral feeding and mechanical ventilation
• not monitoring of residual gastric volume
no measurements of residual gastric volume

Locations

Country	Name	City	State
France	CH Angoulème - Réanimation Polyvalente	Angouleme
France	CHD Vendée - Service de Réanimation	La Roche sur Yon
France	CHU Limoges - Réanimation Polyvalente	Limoges
France	CHU Orléans - Réanimation Médicale	Orleans
France	CHU Poitier - Réanimation Médicale	Poitiers
France	CHU Tours - Réanimation Polyvalente	Tours

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee	University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare ventilator associated pneumonia rates in patients receiving early enteral feeding without residual gastric volume (RGV) monitoring and in patients with RGV monitoring		until weaning of mechanical ventilation (average : 14 days)	Yes
Secondary	mortality rate		60 days	Yes
Secondary	vomiting rates		until weaning of mechanical ventilation (average : 14 days)	No