Sample size calculations utilized an estimated effect size, determined based upon preliminary testing in the model. Using a significance

level of 0.05 and power of 80%, the sample size needed for the trial was conservatively estimated at 12 subjects in each group, 48 total. Results Forty-eight participants were recruited from October 2011 to December 2011 with no excluded participants. The process of subject selection and flow throughout the study is Inhibitors,research,lifescience,medical summarized in a flow-diagram in accordance with the CONSORT Statement (Figure 2) [13,14]. Notably, one participant who should have been assigned to the 60 mL group according to the randomization sequence was incorrectly allocated to and received the 30 mL assignment due to a communication error. This individual was analyzed in the 60 mL group as per intention to treat principles but we also conducted a per protocol analysis of the primary outcome to assess for any potential impact this may have Inhibitors,research,lifescience,medical had on the primary outcome. The

per-protocol analysis failed to show any difference in the primary outcome Inhibitors,research,lifescience,medical analysis result. Further study analyses were therefore conducted using only an intention-to-treat analysis. Figure 2 The Pediatric Fast Fluid Trial flow diagram. No participants were excluded from initial 48 subject recruitment. All subjects completed protocol to analysis. Initial allocation called for 1:1:1:1 syringe size distribution, however one subject was mistakenly … Baseline demographics of the participants as gathered from the post-intervention questionnaire are seen in Table 1. Participants indicated that they were most comfortable using the ‘disconnect-reconnect’ technique as their preferred method of fluid administration for children in shock (48%), though many also preferred the ‘push-pull’ Inhibitors,research,lifescience,medical technique (27%); regular infusion pump was also preferred by 14% (Figure 3). Respondents were asked

to choose one preferred method, however several circled more than one answer on their post-test questionnaire Inhibitors,research,lifescience,medical (48 subjects provided 54 responses). Four respondents did not provide an all answer. Table 1 Baseline demographics of trial participants Figure 3 Preferred techniques of rapid fluid resuscitation as reported by participants. The majority of respondents reported preference for the ‘disconnect-reconnect’ technique of fluid bolusing. The next most commonly cited preference was the … The primary outcome of total fluid delivery time significantly find more differed according to syringe size based on our analysis with one-way ANOVA at p = 0.0012 (Table 2). Post Hoc analysis with Tukey’s HSD demonstrated a significant difference in fluid administration time when comparing the 10 mL group to both the 30 mL and 60 mL groups respectively (Table 3). There did appear to be a trend towards superiority of the 30 mL and 60 mL groups over the 20 mL group, but this was not statistically significant (Figure 4).