6/28/23, 11:38 PM IRIS Cricoid Trial Pathway Feedback Search Clinical Topics Home Studies IRIS Cricoid Trial IRIS Cricoid Trial Trial question Is cricoid pressure noninferior to a sham procedure in patients undergoing rapid sequence induction of anesthesia? Study design Multi-center Double blinded RCT Population Characteristics of study participants 49.0% female N = 3472 51.0% male 3472 patients (1694 female, 1777 male) Inclusion criteria: patients undergoing anesthesia with rapid sequence induction Key exclusion criteria: contraindication for the use of the cricoid pressure or succinylcholine, pneumonia or pulmonary contusion, upper respiratory tract abnormalities, consciousness disorders Interventions N=1735 Sellick maneuver (application of an expected pressure equivalent to 30 N with the first 3 fingers on the cricoid cartilage) N=1736 sham application (fake Sellick maneuver with no pressure application) Primary outcome Pulmonary aspiration 0.6 % 0.6 0.5 0.4 % 0.3 % Difference exceeding nonferiority margin 0.1 % 0.0 % https://web.pathway.md/studies/recZSYWgS04060mzu 1/2 6/28/23, 11:38 PM IRIS Cricoid Trial Pathway Sellick maneuver Sham application Difference exceeding nonferiority margin in pulmonary aspiration (0.6% vs. 0.5%; RR 0.9, 95% CI 0.33 to 2.38) Secondary outcomes Significant increase in tracheal intubation time (27 seconds vs. 23 seconds; AD 4 seconds, 95% CI 1.63 to 6.37) No significant difference in death (2% vs. 2%; ARD -0.2, 95% CI -1 to 0.7) No significant difference in suspected pneumonia within 24 hours (0.9% vs. 0.6%; ARD -0.3, 95% CI -0.8 to 0.3) Safety outcomes No significant differences in adverse events, serious adverse events. Significant differences in intubation time > 30 seconds (47% vs. 40%), interruption of the cricoid pressure (14% vs. 5%). Conclusion In patients undergoing anesthesia with rapid sequence induction, Sellick maneuver was not noninferior to sham application with respect to pulmonary aspiration. Reference Aur lie Birenbaum, David Hajage, Sabine Roche et al. Effect of Cricoid Pressure Compared With a Sham Procedure in the Rapid Sequence Induction of Anesthesia: The IRIS Randomized Clinical Trial. JAMA Surg. 2019 Jan 1;154(1):9-17. Open reference URL https://web.pathway.md/studies/recZSYWgS04060mzu 2/2