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[A comparison of the Proseal laryngeal mask to the standard laryngeal mask on anesthesized, non-relaxed patients].

It was our goal to compare the Proseal-laryngeal mask airway (PLMA) with the classical laryngeal mask airway (LMA) in a german multicenter trial. Handling of the instruments and application criteria were to be tested. 7 anaesthesia departments were able to take part in this study. 280 patients could be investigated after approval of the ethics committee of the medical faculty of the university of Goettingen. 145 patients received the PLMA and 135 the LMA. The surgical interventions were small to moderate procedures with a duration of at least 20 minutes in the sections general surgery, trauma/orthopedic surgery, urology, vascular surgery, gynecology, ENT-surgery and ophthalmology. There was equivalence of the two instruments PLMA and LMA concerning duration and ease of insertion, endoscopic position check, observations on emergence, potential for injury and some postoperative complaints. This equivalence could be confirmed statistically. Laryngospasm was observed in three, Bronchospasm in two patients with the PLMA, in no one with the LMA. In one case of laryngospasm and another of bronchospasm a mechanism of supraglottic laryngeal stenosis has been involved which may occur in rare instances with the PLMA. This mechanism is due to the double cuff of the PLMA with the instruments proximity to the laryngeal inlet. The seal pressure in both groups differs significantly (p = 0.001). The mean value for the seal pressure was 29,3 +/- 0,21 mbar for the PLMA and 20,9 +/- 0,21 mbar for the LMA. In the PLMA the gastric tube could be positioned with the first attempt in 118 patients, with the second attempt in 17 cases. In 10 patients the gastric tube could not be placed. Contrary to the LMA the tip of the PLMA cuff may be bent in some cases with loss of airway safety and positioning of the gastric tube. The symptoms sore throat and painful swallowing on the first postoperative day were more frequent with LMA application. These differences could be confirmed statistically (sore throat p = 0.01, painful swallowing p = 0.04). They may be explained by the more rigid LMA compared to the PLMA and by the fact that the LMA in this study was older than the PLMA, loosing plasticizer. The drainage tube within the PLMA offers safety from aspiration in patients with no primary aspiration risk, additional reassurance for a correct position and a better stability of the airway. Our data may support a wider indication range for the PLMA compared with the LMA. The PLMA may be applied in laparoscopies and lower abdominal surgical interventions. Careful clinical observation will show, if the minimal invasiveness of the PLMA offers an advantage for these patients. The PLMA should not be applied in patients with increased aspiration risk.