The target sample size in this study was 1825 catheters and was calculated as follows: the phlebitis occurrence was 5% of PIVCs according to our pilot study (unpublished), which was reported at the 44th annual meeting of the Society of Japanese Intensive Care Medicine, and the estimated 95% confidence interval (CI) was 3–6%.
Patient characteristics, catheter characteristics, and primary and secondary outcomes were presented as mean with standard deviation (SD) or median with interquartile range (IQR) for continuous variables and percentages for categorical variables. Proportion, time to event, and incidence rate of outcomes were presented as each effect size with two-tailed 95% CIs calculated using the Wilson score interval and Poisson distribution. Analyses were performed using JMP V.10.0 and SAS version 9.4 (SAS Inc, Cary, NC).
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