The ProSeal laryngeal mask airway: A randomized, crossover study with the standard laryngeal mask airway in paralyzed, anesthetized patients.

Abstract

The ProSeal laryngeal mask airway (PLMA) is a new laryngeal mask device with a modified cuff to improve seal and a drainage tube to provide a channel for regurgitated fluid and gastric tube placement. In the present randomized, crossover study, the authors tested the hypothesis that ease of insertion, airway sealing pressure, and fiberoptic position differ between the PLMA and the standard laryngeal mask airway (LMA). For the PLMA, we also assess ease of gastric tube placement and the efficacy of an introducer tool. Sixty paralyzed, anesthetized adult patients were studied. Both devices (only size 4) were inserted into each patient in random order. Airway sealing pressure and fiberoptic position were determined during cuff inflation from 0 to 40 ml in 10-ml increments. Gastric tube insertion was attempted with the PLMA if there was no gas leak from the drainage tube. In 60 additional patients, ease of insertion for the PLMA was compared with and without an introducer. First-time success rates were higher (60 of 60 vs. 52 of 60; P = 0.003) and the effective airway time shorter (9 +/- 3 s vs20 +/- 18 s; P < 0.0001) for the LMA. There were no failed uses of either device within three attempts. Airway sealing pressure was 8-11 cm H2O higher for the PLMA at all cuff volumes (P < 0.00001) and was higher in females for both devices. Fiberoptic position was better with the LMA at all cuff volumes (P < 0.00001), but vocal cord visibility was similar (LMA, 59 of 60; PLMA, 56 of 60). For the PLMA, gastric tube placement was successful in 58 of 58 patients and took 9 +/- 5 s. First-time success rates were higher (59 of 60 vs53/60; P = 0.03) and the effective airway time shorter (15 +/- 13 s vs 23 +/- 18 s; P = 0.008) with the introducer. The PLMA is capable of achieving a more effective seal than the LMA and facilitates gastric tube placement, but it is more difficult to insert unless an introducer tool is used. When correctly positioned, the PLMA isolates the glottis from the upper esophagus with possible implications for airway protection.