Abstract
BACKGROUND: The EasyTube® (EzT) is a supraglottic airway device (SAD) enabling ventilation irrespective of its placement into the esophagus or trachea. Data obtained on SADs from multicenter studies, performed in highly specialized centers cannot always be transferred to other sites. However, data on comparability of different sites are scarce. This study focused on inter-site variability of ventilatory and safety parameters during general anesthesia with the EzT. METHODS: 400 patients with ASA physical status I-II undergoing general anesthesia for elective surgery in four medical centers (EzT group (n = 200), ETT group (n = 200)). Mallampati classification, success of insertion, insertion time, duration of ventilation, number of insertion attempts, ease of insertion, tidal volumes, leakage, hemodynamic parameters, oxygenation, and complications rates with the EasyTube (EzT) or endotracheal tube (ETT) in comparison within the sites and in between the sites were recorded. RESULTS: Intra-site and inter-site comparison of insertion success as primary outcome did not differ significantly. The inter-site comparison of expiratory minute volumes showed that the volumes achieved over the course of anesthesia did not differ significantly, however, mean leakage at one site was significantly higher with the EzT (0.63 l/min, p = 0.02). No significant inter-site differences in heart rate, blood pressure, or oxygenation were observed. Sore throat and blood on the cuff after removal of the device were the most frequent complications with significantly more complications at one site with the EzT (p = 0.01) where insertion was also reported significantly more difficult (p = 0.02). CONCLUSION: Performance of the EzT but not the ETT varied between sites with regard to insertion difficulty, leakage, and complications but not insertion success, ventilation, hemodynamics, and oxygenation parameters in patients with ASA physical status 1-2 during general anesthesia undergoing minor elective surgery.