BACKGROUND The cuffed oropharyngeal airway (COPA) has been recently introduced into the market, but few is known about its clinical use in Italy. We therefore conducted a prospective, observational investigation to evaluate the use of this new extra-tracheal airway in clinical practice. METHODS Anesthesiologists participating in the study received a simple questionnaire where data concerning anthropometric variables, surgical procedure, type and doses of drugs used to induce and maintain general anesthesia, type of ventilation during the procedure, and occurrence of untoward events during either COPA placement, general anesthesia maintenance, or postoperative period were prospectively recorded. The number of previously placed COPA, and the adequacy of airway control (subjective four point scale: excellent, good, fair, and poor) were also assessed. RESULTS A total of 210 patients (139 female and 71 male) were prospectively studied. General anesthesia was induced with propofol in 204 patients (98%), sodium thiopental in 3 patients (1.5%), and midazolam in 1 patient (0.5%); while only one patient received muscle relaxants (0.5%); 126 patients (64%) were spontaneously breathing while 71 patients (36%) received positive pressure mechanical ventilation. No differences in the incidence of untoward events was reported between spontaneously breathing and mechanically ventilated patients. No differences in the incidence of untoward events were reported according to the number of previously placed COPA. Difficulties in COPA placement were reported in 7 patients with normal dentiture (5%) and 9 patients (39%) with dental prosthesis (p = 0.003), (Odds Ratio: 5.1; Cl95%: 3.0-8.7). Furthermore, airway obstruction was more frequently reported in patients with dental prosthesis (8% vs 0%; p = 0.002). The seal pressure was higher in mechanically ventilated (17 +/- 10 cm H2O) than spontaneously breathing patients (10 +/- 8 cm H2O), (p = 0.0005), while a sealing pressure higher than 12 cm H2O was associated with an increased risk for postoperative sore throat (Odds ratio: 4.3; Cl95%: 2.6-7.1; p = 0.002). Airway control was graded as excellent in 61.4% of cases by physician previously placing more than 50 COPA, compared with only 26.5% when less than 50 COPA had been previously placed (p = 0.0005). CONCLUSIONS COPA provided as safe and effective airway management in mechanically ventilated patients as that observed during spontaneous breathing. Experience with COPA placement had no effects on the placement success rate or incidence of untoward events, but improved the quality of airway control.