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Original Investigation
October 17, 2018

Effect of Cricoid Pressure Compared With a Sham Procedure in the Rapid Sequence Induction of AnesthesiaThe IRIS Randomized Clinical Trial

Author Affiliations
  • 1Department of Anesthesiology and Critical Care, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Paris, France
  • 2Sorbonne Université, Department of Biostatistics Public Health and Medical Information, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Paris, France
  • 3Université Jules Verne, Department of Anesthesiology and Critical Care, CHI Amiens-Picardie, Amiens, France
  • 4Department of Anesthesiology and Critical Care, Hôpital Beaujon, Assistance Publique-Hôpitaux de Paris, Clichy, France
  • 5Université de Montpellier, Department of Anesthesiology and Critical Care, Hôpital Carémeau, Nîmes, France
  • 6Department of Anesthesiology and Critical Care, Centre Hospitalier Universitaire Regional de Lille, Lille, France
  • 7Université de Haute-Normandie, Department of Anesthesiology and Critical Care, Hôpital, Rouen, France
  • 8Université Paris-Sud, Department of Anesthesiology and Critical Care, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, Le Kremlin-Bicêtre, France
  • 9Université Victor Segalen, Department of Anesthesiology and Critical Care, Hôpital Pellegrin, Bordeaux, France
  • 10Université Toulouse 3-Paul Sabatier, Department of Anesthesiology and Intensive Care, University Hospital of Toulouse, Toulouse, France
  • 11Department of Anesthesiology and Critical Care, Hôpital Avicenne, Assistance Publique-Hôpitaux de Paris, Bobigny, France
  • 12Department of Anesthesiology, Centre Hospitalier Simone Veil, Cannes, France
  • 13Sorbonne Université, UMR Inserm, Institut hospitalo-universitaire ICAN, Department of Emergency Medicine and Surgery, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Paris, France
JAMA Surg. Published online October 17, 2018. doi:10.1001/jamasurg.2018.3577
Key Points

Question  Does the cricoid pressure prevent pulmonary aspiration in patients undergoing rapid sequence induction of anesthesia?

Findings  In this randomized, noninferiority double-blind trial involving 3472 patients, the results failed to demonstrate the noninferiority of a sham procedure in preventing pulmonary aspiration compared with the cricoid pressure. Mortality, pneumonia, and length of stay did not differ significantly between groups, and differences in intubation time and laryngoscopic exposure suggest more difficulties in the Sellick group.

Meaning  This large randomized trial failed to demonstrate the noninferiority of a sham procedure to prevent pulmonary aspiration during rapid sequence induction of anesthesia.

Abstract

Importance  The use of cricoid pressure (Sellick maneuver) during rapid sequence induction (RSI) of anesthesia remains controversial in the absence of a large randomized trial.

Objective  To test the hypothesis that the incidence of pulmonary aspiration is not increased when cricoid pressure is not performed.

Design, Setting, and Participants  Randomized, double-blind, noninferiority trial conducted in 10 academic centers. Patients undergoing anesthesia with RSI were enrolled from February 2014 until February 2017 and followed up for 28 days or until hospital discharge (last follow-up, February 8, 2017).

Interventions  Patients were assigned to a cricoid pressure (Sellick group) or a sham procedure group.

Main Outcomes and Measures  Primary end point 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.

Results  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. The upper limit of the 1-sided 95% CI of relative risk was 2.00, exceeding 1.50, failing to demonstrate noninferiority (P = .14). The risk difference was −0.06% (2-sided 95% CI, −0.57 to 0.42) in the intent-to-treat population and −0.06% (2-sided 95% CI, −0.56 to 0.43) in the per protocol population. Secondary end points were not significantly different among the 2 groups (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.

Conclusions and Relevance  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.

Trial Registration  ClinicalTrials.gov Identifier: NCT02080754

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