"Prospektive Anwendungsbeobachtung des Einsatzes der ProSeal®-Kehlkopfmaske im klinischen Alltag bei erwachsenen Patienten"

There have been numerous studies published on the ProSeal™ laryngeal mask airway (PLMA). However, few have investigated its utility in a large practice setting. The primary aim of this study was therefore to gather comprehensive data about the characteristics, efficiacy, and safety of its use by a representative group of anesthesiologists working at a teaching center. Information was collected on a standardized data collection form. Clinical information obtained included user characteristics, patient characteristics, type and duration of operation, details of adverse events, and postoperative status of the patient. A total of 2114 PLMA uses were documented in 1288 female and 826 male patients by 81 anesthesiologists (57% trainee, 43% staff grade). The insertion success rate was 99% within a maximum of three attempts. Mean airway leak pressure was 28 (11-40) cm H2O. In 3.2% of cases, the PLMA was abandoned in favor of the endotracheal tube. Ventilation was controlled in 98%. Clincally "relevant" adverse events were recorded in 3.3% of all cases, of which 0.6% were classified as "serious". No long-term adverse sequelae resulted. No signs of aspiration were found in 12 patients with apparent regurgitation of gastric fluid through the drain tube of the PLMA. Five cases of difficult ventilation and 16 cases of difficult endotracheal intubation were successfully managed by the use of the PLMA. This study demonstrates that airway management using the PLMA and a controlled mode of ventilation is both effective and safe in a general practice setting. The results support the assumption that a correctly positioned PLMA can protect patients from pulmonary aspiration of regurgitated gastric fluid. The study underlines the role of inadequate anesthesia if PLMA use is associated with problems or fails. The data also support use of the PLMA for management of the difficult airway.