The CobraPLA(TM) During Anesthesia with Controlled Ventilation: A Clinical Trial of Efficacy

ABSTRACT

The CobraPLA(TM) (CPLA) is a relatively new supraglottic airway device that has not been sufficiently investigated. Here, we performed a prospective observational study to evaluate the efficacy of the CPLA during controlled ventilation. In 50 anesthetized and paralyzed patients undergoing elective surgery a CPLA was inserted and inflated to an intracuff pressure of 60 cm H2O. The success rate of insertion upon the first attempt was 82% (41/50), with a mean insertion time of 16.3 +/- 4.5 seconds. The adequacy of ventilation was assessed by observing the end tidal CO2 waveform, movement of the chest wall, peak airway pressure (13.5 cm H2O), and leak fraction (4%). We documented the airway sealing pressure (22.5 cm H2O) and noted that the the site of gas leaks at that pressure were either at the neck (52%), the abdomen (46%), or both (2%). In 44 (88%) patients, the vocal cords were visible in the fiberoptic view through the CPLA. There was no gastric insufflation during the anesthesia. Respiratory and hemodynamic parameters remained stable during CPLA insertion. Postoperative blood staining of CPLA was minimal, occurring in 22% (11/50) of patients. Mild and moderate throat soreness was reported in 44% (22/50) and 4% (2/50) of patients, respectively. Lastly, mild dysphonia was observed in 6% (3/50) of patients and mild dysphagia in 10% (5/50) of patients. Our results indicated that the CPLA is both easy to place and allows adequate ventilation during controlled ventilation.