Therapy Gastric versus transpyloric feeding in severe traumatic brain injury: a prospective, randomized trial.
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Summary
Posted By:	Elizabeth Sweetman
E-Mail:	esweetman@med.usyd.edu.au
Posted Date:	02.05.2013
Title:	Gastric versus transpyloric feeding in severe traumatic brain injury: a prospective, randomized trial.
Authors:	Acosta-Escribano J, Fernández-Vivas M, Grau Carmona T, Caturla-Such J, Garcia-Martinez M, Menendez-Mainer A, Solera-Suarez M, Sanchez-Payá J.
Reference:	Intensive Care Med. 2010 Sep;36(9):1532-9.
Link:	Click here for a direct link to the paper. A password may be required for access to fulltext.
Abstract:	PURPOSE: To evaluate the efficacy of transpyloric feeding (TPF) compared with gastric feeding (GF) with regard to the incidence of ventilator-associated pneumonia in severe traumatic brain injury patients (TBI). DESIGN AND SETTING: Prospective, open-label, randomized study in an intensive care unit of a university hospital. PATIENTS: One hundred and four CHI adult patients admitted for TBI between April 2007 and December 2008. Patients were included within the first 24 h after ICU admission and were followed until discharge or 30 days after admission. INTERVENTION: Patients were randomized to TPF or GF groups. They received the same diet, with 25 kcal kg(-1) day(-1) of calculated energy requirements and a nitrogen intake of 0.2 g N kg(-1) day(-1). Primary outcome was the incidence of early and ventilatory-associated pneumonia. Secondary outcomes were enteral nutrition-related gastrointestinal complications (GIC), days on mechanical ventilation, length of ICU stay and hospital stay, and sequential organ failure assessment score (SOFA). RESULTS: The TPF group had a lower incidence of pneumonia, OR 0.3 (95% CI 0.1-0.7, P = 0.01). There were no significant differences in other nosocomial infections. The TPF group received higher amounts of diet compared to the GF group (92 vs. 84%, P < 0.01) and had lesser incidence of increased gastric residuals, OR 0.2 (95% CI 0.04-0.6, P = 0.003). CONCLUSIONS: Enteral nutrition delivered through the transpyloric route reduces the incidence of overall and late pneumonia and improves nutritional efficacy in severe TBI patients.
Are the Results Valid?
1. Was the assignment of patients to treatments randomized? ( Was allocation concealment maintained?)
	The assignment of eligible patients to treatment groups was randomised however, authors fail to state method used to randomise patients. Allocation concealment therefore is unclear in this trial. Severe traumatic brain injury patients were randomised to either the Transpyloric Feeding (TPF)Group or the Gastric Feeding (GF) Group.
2. Were all patients who entered the trial properly accounted for and attributed at its conclusion?
2a. Was followup complete?
	Yes all patients were accounted for at the completion of the trial. Figure 1, p. 1535. Yes follow-up was complete.
2b. Were patients analyzed in the groups to which they were randomized?
	Yes the patients were analysed in the groups to which they were radomised as per Table 1 and Table 2. There was however a cross over of three patients from the TPF group to the GF group after unsuccesful transpyloric tube placement (Results section, pg. 1534).
3. Were patients, health workers, and study personnel blind to treatment?
	No. Patients, health works and study personnel were not documented to have been blinded to treatment allocation.
4. Were the groups similar at the start of the trial?
	Study groups were similar at the start of the trial. Time to clinical stabilisation was 2 hours longer in the GF group compared to the TPF group (P = 0.05, Table 1, pg. 1535).
5. Aside from the experimental intervention, were the groups treated equally?
	It is difficult to establish this as there is no discussion by the authors or table in the manuscript regarding treatments received by each study groups whilst they were on study.
What are the Results?
1. How large was the treatment effect?
	Primary Outcome: Incidence of Nosocomial Pneumonia in the ICU - TPF Group had a lower incidence of nosocomial pneumonia 16 (32%) in TPF Group vs 31 (57%) in the GF Group (OR 0.3, P <0.01) Other Outcomes: Mortality at 30 days - No difference 6 (12%) TPF Group vs 9 (16.5%) GF Group (Nil OR, P = 0.4) Abdominal distension: No difference 0 TPF Group vs 2 (4%) in GF Group (OR 1.8, P = 0.5) Increased gastric residuals: Higher in GF group 3 (6%) TPF Group vs 15 (28%) GF Group (OR 0.2, P = 0.003) Diarrhea - 4 (8%) TPF Group vs 8 (15%) GF Group (OR 0.5, P = 0.2) Mean efficacious EN volume - 92 % TPF Group vs 84% GF Group (Nil OR, P < 0.01) Aspiration - 0 TPF Group vs 2 (4%)GF Group (OR 1.8, P = 0.5)
2. How precise was the estimate of the treatment effect?
	Primary Outcome: Incidence of Nosocomial Pneumonia in the ICU - TPF Group vs GF Group (95% CI 0.1 - 0.7) Other Outcomes: Mortality at 30 days - No 95% CI presented Abdominal distension: TPF Group vs GF Group (95% CI 0.2 - 21 ) Increased gastric residuals: TPF Group vs GF Group (95% CI 0.1 - 0.6 ) Diarrhea - TPF Group vs GF Group (95% CI 0.1 - 1.7 ) Mean efficacious EN volume - No 95% CI presented Aspiration - TPF Group vs GF Group (95% CI 0.2 - 21 )
Will the Results Help Me In Caring For My Patients?
1. Can the results be applied to my patient care?
	Yes if your unit is able to / or routinely places transpyloric feeding tubes
2. Were all clinically important outcomes considered?
	Yes important major outcomes were considered. Physical function, quality of life and costs could have been considered.
3. Are the likely treatment benefits worth the potential harms and costs?
	No major harms were demonstrated with transpyloric tubes. A reduction in VAP with transpyloric tubes may be worthwhile.
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