Birenbaum A, et al. - Researchers investigated whether cricoid pressure (Sellick maneuver) prevent pulmonary aspiration in patients undergoing rapid sequence induction of anesthesia. In this randomized, noninferiority double-blind trial involving 3472 patients, patients were assigned to a cricoid pressure (Sellick group) or a sham procedure group. Findings failed to demonstrate the noninferiority of the sham procedure in preventing pulmonary aspiration.

• Researchers conducted a randomized, double-blind, noninferiority trial in 10 academic centers.
• From February 2014 until February 2017, they enrolled patients undergoing anesthesia with rapid sequence induction (RSI); follow up was performed for 28 days or until hospital discharge (last follow-up, February 8, 2017).
• The incidence of pulmonary aspiration (at the glottis level during laryngoscopy or by tracheal aspiration after intubation) was the primary end point.
• They presumed that compared to cricoid pressure, the sham procedure would not be inferior.
• In this study, the secondary end points were related to pulmonary aspiration, difficult tracheal intubation, and traumatic complications owing to the tracheal intubation or cricoid pressure.

• Researchers randomized 3472 patients, mean (SD) age was 51 (19) years and 1777 (51%) were men.
• In 10 patients (0.6%) in the Sellick group and 9 patients (0.5%) in the sham group, pulmonary aspiration occurred.
• The 1-sided 95% CI of relative risk had the upper limit of 2.00, exceeding 1.50, failing to demonstrate noninferiority (P=.14).
• The risk difference in the intent-to- treat population was −0.06% (2-sided 95% CI, −0.57 to 0.42) and in the per protocol population was −0.06% (2-sided 95% CI, −0.56 to 0.43).
• The groups were not significantly different in terms of secondary end points (pneumonia, length of stay, and mortality), although the comparison of the Cormack and Lehane grade (Grades 3 and 4, 10% vs 5%; P <.001) and the longer intubation time (Intubation time >30 seconds, 47% vs 40%; P <.001) suggest an increased difficulty of tracheal intubation in the Sellick group.