To the Editor Birenbaum et al1 compared the effectiveness of cricoid pressure (CP) with a sham procedure in the rapid sequence induction (RSI) of anesthesia. The authors reported that their study failed to demonstrate the noninferiority of the sham procedure in preventing pulmonary aspiration, implying no benefit of CP. However, the use of an inadequate number of patients (1717 per group) raises serious questions about the validity of this conclusion. The calculation of the group size by Birenbaum et al1 was based on the 2.8% incidence of aspiration reported by Martin et al.2 But the use of this value was inappropriate because that study was performed in relation to emergency intubations outside the operating room, where a higher aspiration rate would be expected. Assuming a more realistic incidence of aspiration in the operating room of 0.15%, a clinical trial assessing the effectiveness of CP would require 2 groups of at least 25 000 patients each. Clearly, the study by Birenbaum et al1 was not sufficiently powered to detect a difference between the CP and sham groups and was vulnerable to a false-negative error.3
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Khorasani A, Salem MR, Crystal GJ. Utility of Cricoid Pressure. JAMA Surg. Published online February 27, 2019154(6):563. doi:10.1001/jamasurg.2018.5849
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