A multicenter study of the Ambu laryngeal mask in nonparalyzed, anesthetized patients.

Abstract

We designed this multicenter trial to evaluate the performance and safety of the Ambu laryngeal mask, a new disposable supraglottic airway device, in patients scheduled for elective surgery. One-hundred-eighteen nonparalyzed, anesthetized patients (ASA physical status I-II, age, 18-65 yr, body mass index, 18-30 kg/m(-2)) receiving total IV anesthesia were included in this study. After device insertion, fiberoptic position and oropharyngeal leak pressure were determined at an intracuff pressure of 60 cm H2O. Ease of ventilation was determined by controlling ventilation at 6 mL/kg tidal volume. Any complications were noted and recorded. Device placement was successful in all patients on the first or second attempt (92.4% or 7.6%, respectively) with an insertion time (removal of face mask until first tidal volume) of 44.9 +/- 37.91 s. Adequate ventilation was achieved in all patients and the vocal cords could be visualized by fiberoptic endoscopy in 91.5% of patients. Oropharyngeal leak pressures were 24.1 +/- 5.44 cm H2O. Blood was detected on the device in 8.5% of patients. Complications and patient complaints were minor and quickly resolved. The Ambu laryngeal mask is easy and quick to insert and provides a safe and efficient seal during positive pressure ventilation in nonparalyzed patients scheduled for elective surgery.