Aurélie Birenbaum1, David Hajage2, Sabine Roche1, Alexandre Ntouba3, Mathilde Eurin4, Philippe Cuvillon5, Aurélien Rohn6, Vincent Compere7, Dan Benhamou8, Matthieu Biais9, Remi Menut10, Sabiha Benachi11, François Lenfant12, Bruno Riou13. 1. Department of Anesthesiology and Critical Care, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Paris, France. 2. Sorbonne Université, Department of Biostatistics Public Health and Medical Information, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Paris, France. 3. Université Jules Verne, Department of Anesthesiology and Critical Care, CHI Amiens-Picardie, Amiens, France. 4. Department of Anesthesiology and Critical Care, Hôpital Beaujon, Assistance Publique-Hôpitaux de Paris, Clichy, France. 5. Université de Montpellier, Department of Anesthesiology and Critical Care, Hôpital Carémeau, Nîmes, France. 6. Department of Anesthesiology and Critical Care, Centre Hospitalier Universitaire Regional de Lille, Lille, France. 7. Université de Haute-Normandie, Department of Anesthesiology and Critical Care, Hôpital, Rouen, France. 8. Université Paris-Sud, Department of Anesthesiology and Critical Care, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, Le Kremlin-Bicêtre, France. 9. Université Victor Segalen, Department of Anesthesiology and Critical Care, Hôpital Pellegrin, Bordeaux, France. 10. Université Toulouse 3-Paul Sabatier, Department of Anesthesiology and Intensive Care, University Hospital of Toulouse, Toulouse, France. 11. Department of Anesthesiology and Critical Care, Hôpital Avicenne, Assistance Publique-Hôpitaux de Paris, Bobigny, France. 12. Department of Anesthesiology, Centre Hospitalier Simone Veil, Cannes, France. 13. Sorbonne Université, UMR Inserm, Institut hospitalo-universitaire ICAN, Department of Emergency Medicine and Surgery, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Paris, France.
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.
RCT Entities:
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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