CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
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Does the ProSeal laryngeal mask airway prevent aspiration of regurgitated fluid?

In this randomized, cross-over cadaver study, we determined whether a new airway device, the ProSeal laryngeal mask airway (PLMA; Laryngeal Mask Company, Henley-on-Thames, UK), prevents aspiration of regurgitated fluid. We studied five male and five female cadavers (6-24 h postmortem). The infusion set of a pressure-controlled, continuous flow pump was inserted into the upper esophagus and ligated into place. Esophageal pressure (EP) was increased in 2-cm H(2)O increments. This was performed without an airway device (control) and over a range of cuff volumes (0-40 mL) for the classic laryngeal mask airway (LMA), the PLMA with the drainage tube clamped (PLMA clamped) and unclamped (PLMA unclamped). The EP at which fluid was first seen with a fiberoptic scope in the hypopharynx (control), above or below the cuff, or in the drainage tube, was noted. Mean EP at which fluid was seen without any airway device was 9 (range 8-10) cm H(2)O. EP at which fluid was seen was always higher for the PLMA clamped and LMA compared with the control (all, P<0.0001). The mean EP at which fluid was seen for the PLMA unclamped was similar to the control at 10 (range 8-13) cm H(2)O. For the PLMA unclamped, fluid appeared from the drainage tube in all cadavers at 10-40 mL cuff volume and in 8 of 10 cadavers at zero cuff volume. Mean EP at which fluid was seen above the cuff was similar for the PLMA clamped and LMA at 0-30 mL cuff volume, but was higher for PLMA clamped at 40-mL cuff volume (81 vs 48 cm H(2)O, P = 0.006). Mean EP at which fluid was seen below the cuff was similar at 0-10 mL cuff volume, but was higher for the PLMA clamped at 20, 30, and 40 mL cuff volume (62, 68, 73 vs. 46, 46, 46 cm H(2)O, respectively, P<0.04). For the PLMA clamped and the LMA, fluid appeared simultaneously above and below the cuff at all cuff volumes. We concluded that in the cadaver model, the correctly placed PLMA allows fluid in the esophagus to bypass the pharynx and mouth when the drainage tube is open. Both the LMA, and PLMA with a closed drainage tube, attenuate liquid flow between the esophagus and pharynx. This may have implications for airway protection in unconscious patients.

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