Enhanced Protein-Energy Provision via the Enteral Route Feeding Protocol in Critically Ill Patients: Results of a Cluster Randomized Trial

Objectives: To determine the effect of the enhanced proteinenergy provision via the enteral route feeding protocol, combined with a nursing educational intervention on nutritional intake, compared to usual care. Design: Prospective, cluster randomized trial. Setting: Eighteen ICUs from United States and Canada with low baseline nutritional adequacy. Patients: One thousand fifty-nine mechanically ventilated, critically ill patients. Interventions: A novel feeding protocol combined with a nursing educational intervention. Measurements and Main Results: The two primary efficacy outcomes were the proportion of the protein and energy prescriptions received by study patients via the enteral route over the first 12 days in the ICU. Safety outcomes were the prevalence of vomiting, witnessed aspiration, and ICU-acquired pneumonia. The proportion of prescribed protein and energy delivered by enteral nutrition was greater in the intervention sites compared to the control sites. Adjusted absolute mean difference between groups in the protein and energy increases were 14% (95% CI, 5-23%; p = 0.005) and 12% (95% CI, 5-20%; p = 0.004), respectively. The intervention sites had a similar improvement in protein and calories when appropriate parenteral nutrition was added to enteral sources. Use of the enhanced protein-energy provision via the enteral route feeding protocol was associated with a decrease in the average time from ICU admission to start of enteral nutrition compared to the control group (40.7-29.7 hr vs 33.6-35.2 hr, p = 0.10). Complication rates were no different between the two groups. Conclusions: In ICUs with low baseline nutritional adequacy, use of the enhanced protein-energy provision via the enteral route feeding protocol is safe and results in modest but statistically significant increases in protein and calorie intake.