Efficacy of a new dual channel laryngeal mask airway, the LMA®Gastro™ Airway, for upper gastrointestinal endoscopy: a prospective observational study.

ABSTRACT

BACKGROUND: Significant cardiorespiratory events are frequent in patients undergoing gastrointestinal endoscopy. Central to the occurrence of respiratory events is an unsecured airway. This study sought to determine the efficacy of a new laryngeal mask airway, the LMA®GastroTM Airway (Teleflex Medical, Athlone, Ireland), in patients undergoing upper gastrointestinal endoscopy. New design features include a dedicated channel for oesophageal intubation and separate channel with terminal cuff for lung ventilation. METHODS: In a prospective, open label, observational study, 292 ASA physical status classification 1 and 2 patients at low risk of pulmonary aspiration undergoing upper gastrointestinal endoscopy received i.v. propofol anaesthesia and standardized insertion of the LMA®GastroTM Airway. Endoscopy outcomes included insertion success, first attempt success, and ease of endoscope insertion. LMA®GastroTM Airway outcomes included insertion success, first attempt success, ease of insertion, lowest oxygen saturation, airway compromise, laryngospasm, bloodstained device, and sore throat. RESULTS: Per protocol analysis (n=290), the endoscopy success rate amongst the cohort with successful LMA®GastroTM Airway insertion was 99% [95% confidence interval (CI) 98, 100]. LMA®GastroTM Airway insertion success rate (n=292) was 99% (95% CI 98, 100). For endoscopy and LMA®GastroTM Airway insertion success, the lower limit of the 95% CIs was at least 98%, indicating LMA®GastroTM Airway efficacy. Median (inter-quartile range) lowest intraoperative oxygen saturation was 98% (98, 99). Only one serious adverse event occurred (re-admission for sore throat and inability to tolerate fluids) and was reported to the Tasmanian Health and Medical Human Research Ethics Committee. CONCLUSIONS: The LMA®GastroTM Airway appears effective for clinical use in upper gastrointestinal endoscopy. CLINICAL TRIAL REGISTRATION ACTRN12616001464459.