Study of Impact of Not Measuring Residual Gastric Volume on Nosocomial Pneumonia Rates (NUTRIREA1)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ventilation-Associated Pneumonia |
Procedure: monitoring of residual gastric volume Procedure: not monitoring of residual gastric volume |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
- 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 ]
- 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 ]
| Enrollment: | 452 |
| Study Start Date: | May 2010 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| residual gastric volume |
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
|
| residual gastric volume not monitored |
Procedure: not monitoring of residual gastric volume
no measurements of residual gastric volume
Other Name: Non residual Gastric Measurement
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| France | |
| CH Angoulème - Réanimation Polyvalente | |
| Angouleme, France | |
| CHD Vendée - Service de Réanimation | |
| La Roche sur Yon, France, 85000 | |
| CHU Limoges - Réanimation Polyvalente | |
| Limoges, France | |
| CHU Orléans - Réanimation Médicale | |
| Orleans, France | |
| CHU Poitier - Réanimation Médicale | |
| Poitiers, France | |
| CHU Tours - Réanimation Polyvalente | |
| Tours, France | |
| Principal Investigator: | Jean REIGNIER, MD, PhD | CHD Vendée |
More Information
No publications provided by Centre Hospitalier Departemental Vendee
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Centre Hospitalier Departemental Vendee |
| ClinicalTrials.gov Identifier: | NCT01137487 History of Changes |
| Other Study ID Numbers: | NUTRIREA1 |
| Study First Received: | May 19, 2010 |
| Last Updated: | February 28, 2013 |
| Health Authority: | France: Institutional Ethical Committee France: French Data Protection Authority |
Keywords provided by Centre Hospitalier Departemental Vendee:
|
mechanical ventilation enteral nutrition Ventilation-Associated Pneumonia residual gastric volume measurement vomiting |
gastro-oesophageal reflux early enteral nutrition Intensive care unit Enteral Feeding |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 22, 2013