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Recommendations Summary

CI: Blue Dye Use in Enteral Nutrition 2012

Click here to see the explanation of recommendation ratings (Strong, Fair, Weak, Consensus, Insufficient Evidence) and labels (Imperative or Conditional). To see more detail on the evidence from which the following recommendations were drawn, use the hyperlinks in the Supporting Evidence Section below.

  • Recommendation(s)

    CI: Blue Dye Use in Enteral Nutrition

    The Registered Dietitian (RD) should recommend against adding blue dye to enteral nutrition (EN) for detection of aspiration in critically ill adult patients. Research shows that the risk of using blue dye outweighs any perceived benefit. The presence of blue dye in tracheal secretions is not a sensitive indicator for aspiration.

    Rating: Strong

    • Risks/Harms of Implementing This Recommendation

      There are no potential risks or harms associated with the application of this recommendation. 

    • Conditions of Application

      Challenges to Implementation: Prior beliefs or practices about the perceived effectiveness of using blue dye may be a barrier to implementing this recommendation.

    • Potential Costs Associated with Application

      No obvious costs are associated with the application of this recommendation.

    • Recommendation Narrative

      After review of the recommendation, the expert work group determined that recent evidence would not affect this statement. Thus, the recommendation is based on the original evidence analysis. Please see the methodology for guideline revisions for more information.

      A total of ten studies were included in the evidence analysis for this recommendation:

      • One positive quality case review (Czop and Herr, 2002)
      • One positive quality consensus statement (McClave et al, 2002)
      • One positive quality diagnostic test study (Metheny et al, 2002)
      • One positive quality non-randomized trial (Potts et al, 1993)
      • Two neutral quality case reports (Thompson-Henry and Braddock, 1995; and Zillich et al, 2000)
      • One negative quality descriptive analysis of two case reports (Sills and Zinkham, 1994)
      • One negative quality literature review (Metheny and Clouse, 1997)
      • One negative quality case report (File et al,  1995)
      • One negative quality review (Maloney et al, 2002).

      Blue Dye and Risk of Mortality

      • Five studies provide weak, but non-conflicting evidence that blue dye administered in an excessive dose or to patients with increased gastrointestinal (GI) permeability increases mortality risk
      • Evidence is based on the following studies: Czop and Herr, 2002; File et al,  1995; Maloney et al, 2002; Sills and Zinkham, 1994; and Zillich et al, 2000. 

      Risk vs. Benefit

      • Ten studies provide evidence that the risk of using blue dye outweighs the potential benefit and that the blue dye method should be abandoned in EN 
      • Evidence is based on the following studies: Czop and Herr, 2002; File et al,  1995; Maloney et al, 2002; McClave et al, 2002; Metheny et al, 2002; Metheny and Clouse, 1997; Potts et al, 1993; Sills and Zinkham, 1994; Thompson-Henry and Braddock, 1995; and Zillich et al, 2000.

      Effectiveness of Blue Dye

      • Four studies provide non-conflicting evidence that blue dye is not sensitive in detecting aspiration
      • Evidence is based on the following studies: Metheny et al, 2002; Metheny and Clouse, 1997; Potts et al, 1993; and Thompson-Henry and Braddock, 1995.

      Additional Information (Not Used in Evidence Analysis)

      • The Food and Drug Administration (FDA) Public Health Advisory (2003) indicated a causal relationship between systemic absorption of Blue Dye No. 1 and reported serious life-threatening patient outcomes has not been definitively established
      • Safety of Blue Dye No. 1-tinted enteral feedings for detecting aspiration is not documented
      • Patients at risk for increased intestinal permeability, including sepsis, burns, trauma, shock, post-surgical renal failure, celiac sprue and inflammatory bowel disease, appear to be at risk of absorbing Blue Dye No. 1 from tinted feedings
      • Metheny et al, 2002, used an animal model to determine if gastric juice stained with blue dye was visible in suctioned tracheobronchial secretions, following three forced small-volume pulmonary aspirations
      • The dye method was only 46.3% sensitive in detecting multiple forced aspirations
      • Although the extent to which this animal study can be extrapolated to humans is unknown, the clinical significance of potential false-negative reports in detection of aspiration may be important. 

    • Recommendation Strength Rationale

      • Non-conflicting evidence from case reports and one review indicates that use of blue food coloring in EN may contribute to increased mortality
      • Blue dye is not sensitive in detecting aspiration, based on non-conflicting evidence from one non-randomized trial, one sensitivity and specificity study, two reviews, a consensus statement, an FDA public health advisory and five case-reports
      • Grade III evidence is available for the following conclusion statements regarding:  
        • Impact of blue dye in EN on mortality
        • Relative risk and benefit of using blue dye in EN
        • Use of blue dye in EN in the detection of aspiration.

    • Minority Opinions