New supraglottic airway with built-in pressure indicator decreases postoperative pharyngolaryngeal symptoms: a randomized controlled trial.

PURPOSE: Excessive supraglottic airway cuff pressure increases postoperative pharyngolaryngeal symptoms such as sore throat, dysphonia, and dysphagia. A new supraglottic airway, AES Ultra CPV™ (CPV), has a built-in intracuff pressure indicator. We hypothesized that using the CPV would reduce postoperative symptoms when compared with the LMA Classic™ (LMA) without intracuff pressure guidance.
METHODS: Ambulatory patients undergoing general anesthesia were randomized to either CPV or LMA. A size 3/4/5 was inserted according to manufacturer guidelines. Nitrous oxide was not used. In the LMA Group, the cuff was inflated according to manufacturer's guidelines. In the CPV Group, a CPV was inserted and the cuff inflated until the indicator was in the green zone (30-44 mmHg). Intracuff pressures were measured at five minutes and 20 min post-insertion in both groups. The primary outcome was the incidence of pharyngolaryngeal symptoms, defined as sore throat, dysphonia, and/or dysphagia at one, two, and/or 24 hr postoperatively. Continuous data were compared using Student's t test and categorical data were analyzed using Chi square analysis.
RESULTS: The study included 170 patients, 85 per group. The mean (SD) intracuff pressure in the CPV group was significantly lower [44 (4) mmHg] than in the LMA Group [87 (37) mmHg]; P < 0.001. The incidence of pharyngolaryngeal symptoms was significantly lower in the CPV Group than in the LMA Group (26% vs 49%; P = 0.002). The absolute risk reduction was 24%, and the number-needed-to-treat was 4.3.
CONCLUSION: The incidence of postoperative pharyngolaryngeal symptoms in the CPV Group with a cuff pressure-guided strategy was significantly lower than in the LMA Group with standard practice. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01800344).

RCT Entities:   Population Interventions Outcomes