A randomised controlled trial comparing ProSeal laryngeal mask airway, i-gel and Laryngeal Tube Suction-D under general anaesthesia for elective surgical patients requiring controlled ventilation

一项随机对照试验比较了在全身麻醉下,ProSeal喉罩气道、i-gel喉罩和喉管吸痰器(Laryngeal Tube Suction-D)在需要控制通气的择期手术患者中的应用。

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Abstract

BACKGROUND AND AIMS: The ProSeal™ laryngeal mask airway (PLMA), i-gel™ and Laryngeal Tube Suction-D (LTS-D™) have previously been evaluated alone or in pair-wise comparisons but differing study designs make it difficult to compare the results. The aim of this study was to compare the clinical performance of these three devices in terms of efficacy and safety in patients receiving mechanical ventilation during elective surgical procedures. METHODS: This prospective, randomised, double-blind study was conducted on 150 American Society of Anesthesiologists physical status I-II patients, randomly allocated into 3 groups, undergoing elective surgical procedures under general anaesthesia. PLMA, i-gel™ or LTS-D™ appropriate for weight or/and height was inserted. Primary outcome measured was airway sealing pressure. Insertion time, ease of insertion, number of attempts, overall success rate and the incidence of airway trauma and complications were also recorded. Intergroup differences were compared using one-way analysis of variance with post hoc correction for continuous data and Chi-square test for categorical variables. RESULTS: Overall success rate was comparable between the three devices (i-gel™ 100%, LTS-D™ 94%, PLMA 96%). Airway sealing pressure was lower with i-gel™ (23.38 ± 2.06 cm H(2)O) compared to LTS-D™ (26.06 ± 2.11 cm H(2)O) and PLMA (28.5 ± 2.8 cm H(2)O; P < 0.0005). The mean insertion time was significantly more in PLMA (38.77 ± 3.2 s) compared to i-gel™ (27.9 ± 2.53 s) and LTS-D™ (21.66 ± 2.31 s; P < 0.0005). CONCLUSION: Airway sealing pressure and insertion time were significantly higher in PLMA compared to i-gel™ and LTS-D™.

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