Study of Impact of Not Measuring Residual Gastric Volume on Nosocomial Pneumonia Rates
- Conditions
- Ventilation-Associated Pneumonia
- Interventions
- Procedure: monitoring of residual gastric volumeProcedure: not monitoring of residual gastric volume
- Registration Number
- NCT01137487
- Lead Sponsor
- Centre Hospitalier Departemental Vendee
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 452
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description residual gastric volume monitoring of residual gastric volume - residual gastric volume not monitored not monitoring of residual gastric volume -
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method mortality rate 60 days vomiting rates until weaning of mechanical ventilation (average : 14 days)
Trial Locations
- Locations (6)
CH Angoulème - Réanimation Polyvalente
🇫🇷Angouleme, France
CHU Orléans - Réanimation Médicale
🇫🇷Orleans, France
CHD Vendée - Service de Réanimation
🇫🇷La Roche sur Yon, France
CHU Limoges - Réanimation Polyvalente
🇫🇷Limoges, France
CHU Tours - Réanimation Polyvalente
🇫🇷Tours, France
CHU Poitier - Réanimation Médicale
🇫🇷Poitiers, France