To the Editor We congratulate Birenbaum et al1 for performing this multicenter, prospective, double-blind randomized clinical trial with 3472 patients that were consented and enrolled in an emergency setting, which showed that the efficiency of a sham maneuver is not inferior to that of the Sellick maneuver. However, as the authors mentioned, they overestimated the incidence of aspiration, since they used a study that looked at the incidence in an emergency setting2; thus, their sample size was underpowered to detect the true difference. This is the issue with all other rare event-type complications and illustrates the difficulty in performing an adequate randomized clinical trial with such an enormous number of participants. This is a major limitation of the present study, which the authors regrettably failed to list in their Limitations section.1
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Knezevic NN, Aghajani K, Candio KD. Utility of Cricoid Pressure. JAMA Surg. 2019;154(6):563–564. doi:10.1001/jamasurg.2018.5850
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