Context: A comparison of the efficacy and safety of the Laryngeal Mask Airway (LMA) Supreme (LMAS) versus the LMA Proseal (LMAP) in elective laparoscopic cholecystectomy.
Objectives: To compare the LMAS with LMAP in terms of ventilatory efficacy, airway leak pressure (airway protection), ease-of-use and complications.
Design: Prospective, single-blind, randomised, controlled study.
Setting: The Hospital del Sureste and Hospital Ramon y Cajal, Madrid, between May 2009 and March 2011. The Hospital del Sureste is a secondary hospital and Hospital Ramon y Cajal is a tertiary hospital.
Patients: Patients undergoing elective laparoscopic cholecystectomy were studied following informed consent. Inclusion criteria were American Society of Anesthesiologists physical status I to III and age 18 or more. Exclusion criteria were BMI more than 40 kg m, symptomatic hiatus hernia or severe gastro-oesophageal reflux.
Interventions: Anaesthesiologists experienced in the use of LMAP and LMAS participated in the trial. One hundred twenty-two patients were randomly allocated to LMAS or LMAP.
Main outcome measures: Our primary outcome measure was the oropharyngeal leak pressure (OLP). Secondary outcomes were the time and number of attempts for insertion, ease of insertion of the drain tube, adequacy of ventilation and the incidence of complication. Patients were interviewed postoperatively to evaluate the presence of sore throat, dysphagia or dysphonia.
Results: Two patients were excluded when surgery changed from laparoscopic to open. A total of 120 patients were finally included in the analysis. The mean OLP in the LMAP group was significantly higher than that in the LMAS group (30.7 ± 6.2 versus 26.8 ± 4.1 cmH2O;P < 0.01). This was consistent with a higher maximum tidal volume achieved with the LMAP compared to the LMAS (511 ± 68 versus 475 ± 55 ml; P = 0.04). The success rate of the first attempt insertion was higher for the LMAS group than the LMAP group (96.7 and 71.2%, respectively; P < 0.01). The time taken for insertion, ease of insertion of the drain tube, complications and postoperative pharyngolaryngeal adverse events were similar in both groups.
Conclusion: The LMAP has a higher OLP and achieves a higher maximum tidal volume compared to the LMAS, in patients undergoing elective laparoscopic cholecystectomy. The success of the first attempt insertion was higher for the LMAS.