Clinical trial NCT01137487: Study of Impact of Not Measuring Residual Gastric Volume on Nosocomial Pneumonia Rates
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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
Collaborators: name: University Hospital, Tours
First posted: 2010-06-04
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
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
timeFrame: until weaning of mechanical ventilation (average : 14 days)
Secondary outcomes:
measure: mortality rate
timeFrame: 60 days
measure: vomiting rates
timeFrame: until weaning of mechanical ventilation (average : 14 days)
Other outcomes:
Locations:
city: Angouleme
country: France
facility: CH Angoulème - Réanimation Polyvalente
city: La Roche sur Yon
country: France
facility: CHD Vendée - Service de Réanimation
city: Limoges
country: France
facility: CHU Limoges - Réanimation Polyvalente
city: Orleans
country: France
facility: CHU Orléans - Réanimation Médicale
city: Poitiers
country: France
facility: CHU Poitier - Réanimation Médicale
city: Tours
country: France
facility: CHU Tours - Réanimation Polyvalente
Study officials:
affiliation: CHD Vendée
name: Jean REIGNIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.