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Study of Impact of Not Measuring Residual Gastric Volume on Nosocomial Pneumonia Rates (NUTRIREA1)

C

Centre Hospitalier Departemental Vendee

Status

Completed

Conditions

Ventilation-Associated Pneumonia

Treatments

Procedure: not monitoring of residual gastric volume
Procedure: monitoring of residual gastric volume

Study type

Interventional

Funder types

Other

Identifiers

NCT01137487
NUTRIREA1

Details and patient eligibility

About

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.

Enrollment

452 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

452 participants in 2 patient groups

residual gastric volume
Other group
Treatment:
Procedure: monitoring of residual gastric volume
residual gastric volume not monitored
Other group
Treatment:
Procedure: not monitoring of residual gastric volume

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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