This large randomized clinical trial performed in patients undergoing anesthesia with RSI failed to demonstrate the noninferiority of the sham procedure in preventing pulmonary aspiration. Further studies are required in pregnant women and outside the operating room. Of 3472 patients randomized, mean (SD) age was 51 (19) years and 1777 (51%) were men. The primary end point, pulmonary aspiration, occurred in 10 patients (0.6%) in the Sellick group and in 9 patients (0.5%) in the sham group. Primary endpoint was the incidence of pulmonary aspiration (at the glottis level during laryngoscopy or by tracheal aspiration after intubation). It was hypothesized that the sham procedure would not be inferior to the cricoid pressure. The secondary end points were related to pulmonary aspiration, difficult tracheal intubation, and traumatic complications owing to the tracheal intubation or cricoid pressure.

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