A Multicenter Study Comparing the ProSealTM and ClassicTM Laryngeal Mask Airway in Anesthetized, Nonparalyzed Patients

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Abstract

The laryngeal mask airway ProSeal (PLMA), a new laryngeal mask device, was compared with the laryngeal mask airway Classic (LMA) with respect to: (1) insertion success rates and times; (2) efficacy of seal; (3) fiberoptically determined anatomic position; (4) orogastric tube insertion success rates and times; (5) total intraoperative complications; and (6) postoperative sore throat in nonparalyzed adult patients undergoing general anesthesia, hypothesizing that these would be different. Three hundred eighty-four nonparalyzed anesthetized adult patients (American Society of Anesthesiologists physical status I-II) were randomly allocated to the PLMA or LMA for airway management. In addition, 50% of patients were randomized for orogastric tube placement. Unblinded observers collected intraoperative data, and blinded observers collected postoperative data. First-attempt insertion success rates (91 vs. 82%, P = 0.015) were higher for the LMA, but after three attempts success rates were similar (LMA, 100%; PLMA, 98%). Less time was required to achieve an effective airway with the LMA (31 +/- 30 vs. 41 +/- 49 s; P = 0.02). The PLMA formed a more effective seal (27 +/- 7 vs. 22 +/- 6 cm H2O; P < 0.0001). Fiberoptically determined anatomic position was better with the LMA (P < 0.0001). Orogastric tube insertion was more successful after two attempts (88 vs. 55%; P < 0.0001) and quicker (22 +/- 18 vs. 38 +/- 56 s) with the PLMA. During maintenance, the PLMA failed twice (leak, stridor) and the LMA failed once (laryngospasm). Total intraoperative complications were similar for both groups. The incidence of postoperative sore throat was similar. In anesthetized, nonparalyzed patients, the LMA is easier and quicker to insert, but the PLMA forms a better seal and facilitates easier and quicker orogastric tube placement. The incidence of total intraoperative complications and postoperative sore throat are similar.

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Comparison of four methods for assessing airway sealing pressure with the laryngeal mask airway in adult patients.

Matthew Keller, J Brimacombe, Sheldon R. Morris … (1999)

We have compared four tests for assessing airway sealing pressure with the laryngeal mask airway (LMA) to test the hypothesis that airway sealing pressure and inter-observer reliability differ between tests. We studied 80 paralysed, anaesthetized adult patients. Four different airway sealing pressure tests were performed in random order on each patient by two observers blinded to each other's measurements: test 1 involved detection of an audible noise; test 2 was detection of end-tidal carbon dioxide in the oral cavity; test 3 was observation of the aneroid manometer dial as the pressure increased to note the airway pressure at which the dial reached stability; and test 4 was detection of an audible noise by neck auscultation. Mean airway sealing pressure ranged from 19.5 to 21.3 cm H2O and intra-class correlation coefficient was 0.95-0.99. Inter-observer reliability of all tests was classed as excellent. The manometric stability test had a higher mean airway sealing pressure (P < 0.0001) and better inter-observer reliability (P < 0.0001) compared with the three other tests. We conclude that for clinical purposes all four tests are excellent, but that the manometric stability test may be more appropriate for researchers comparing airway sealing pressures.

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A fibreoptic scoring system to assess the position of laryngeal mask airway devices. Interobserver variability and a comparison between the standard, flexible and intubating laryngeal mask airways.

F Pühringer, Matthew Keller, J Brimacombe (2000)

We determined the interobserver reliability of a fibreoptic scoring system for assessing the position of the laryngeal mask airway (LMA), the flexible laryngeal mask airway (FLMA) and the intubating laryngeal mask airway (ILM). We also compare fibreoptic position between the devices. Thirty anaesthetised adult patients were studied in random order in a triple crossover manner. Two observers blinded to each others findings scored the fibreoptic position as follows: 4, only vocal cords visible; 3, vocal cords plus posterior epiglottis visible; 2, vocal cords plus anterior epiglottis visible; 1, vocal cords not seen. Interobserver reliability was examined using intraclass correlation coefficient (ICC). Interobserver reliability was graded as excellent for the LMA (ICC = 0.89), FLMA (ICC = 0.87) and ILM (ICC = 0.79). Fibreoptic scores were higher for the LMA and FLMA compared with the ILM (both p < 0.001). We conclude that interobserver reliability for the fibreoptic scoring system is excellent for the LMA, FLMA and ILM. Fibreoptic position is better for the LMA and FLMA compared with the ILM. Fibreoptic scoring has potential utility for research and clinical practice with laryngeal mask devices.