Laryngeal tube suction II or endotracheal intubation for laparoscopic radical prostatectomy in a head down position: A randomised controlled trial.

BACKGROUND: The laryngeal tube suction II (LTS II) is a supraglottic airway device (SAD) with a gastric drainage tube and enhanced seal properties as compared with other SADs. Therefore, its use has been proposed in situations with an elevated risk of aspiration. OBJECTIVES: To compare the safety and efficacy of airway management and controlled mechanical ventilation when using either an LTS II or an endotracheal tube for laparoscopic radical prostatectomy. DESIGN: Randomised, controlled, blinded and single-centre study. SETTING: Academic tertiary care centre in Leipzig from April 2014 to May 2015. PATIENTS: It was planned to include 100 patients but the study was stopped after 50 patients following an interim analysis. These 50 patients were randomised to either the LTS II group or the endotracheal tube group. All male patients aged more than 18 years for elective laparoscopic radical prostatectomy were eligible. Exclusion criteria included a BMI more than 30, American Society of Anesthesiologists class III or greater, a history of gastroesophageal reflux or other factors known to increase the risk of aspiration and a known difficult airway. INTERVENTIONS: All patients received general anaesthesia. Airway management was with either a LTS II or an endotracheal tube, according to the randomisation. MAIN OUTCOME MEASURES: The primary endpoint was successful insertion of the particular airway device during anaesthesia for laparoscopic radical prostatectomy. RESULTS: In 15 of the 28 patients randomised to LTS II, the device had to be removed and an endotracheal tube inserted, mainly because of an airway leak (n = 10) or swelling of the tongue (n = 3). Ventilation was successful in all patients (n = 22) randomised to endotracheal tube. Quality of ventilation was rated better in the endotracheal tube group. CONCLUSION: Our data suggest that LTS II should not be the preferred method of airway management in patients undergoing laparoscopic radical prostatectomy. TRIAL REGISTRATION: DRKS00008985 (German Clinical Trials Register).