Individualized regulation of inflatable laryngeal mask airway cuff pressure reduces postoperative pharyngolaryngeal pain in elderly patients: a randomized controlled trial.

Abstract

Inflatable laryngeal mask airway (ILMA) cuff pressure lacks routine monitoring and standardized safe thresholds, with clinical practice often referencing manufacturer specifications. Empirical inflation in clinical practice often leads to overinflation and increased pharyngolaryngeal complications. This study established an individualized ILMA cuff pressure regulation strategy based on physiological characteristics and sealing principles, aiming to compare its effect on postoperative pharyngolaryngeal pain in elderly patients with empirical inflation. This single-center, double-blind randomized controlled trial comprised 78 elderly patients undergoing general anesthesia with ILMA. Patients were randomly assigned to either the empirical inflation (EI) group or the individualized regulation and real-time monitoring (RM) group. In group EI, the cuff was inflated empirically. In group RM, individualized regulation and real-time monitoring were applied: cuff pressure was adjusted to maintain &#x2265; peak airway pressure, with the oropharyngeal leak pressure (OLP)&#x202f;&#x2265;&#x202f;25 cmH₂O. The primary outcome was the incidence of pharyngolaryngeal pain within 48&#x202f;h after ILMA removal. The secondary outcomes included other pharyngolaryngeal complications (e.g., supraglottic mucosal injury graded by fiberoptic bronchoscopy), 7-day pulmonary complications assessed by the Postoperative Pulmonary Complications (PPCs) scale and other prespecified secondary outcomes. 78 elderly patients were randomized, and 74 completed the study. Cuff pressure was significantly higher in group EI than in group RM (<i>p&#x202f;&lt;</i> 0.001), with no between-group differences in ILMA positioning accuracy or ventilation sealing performance (<i>p&#x202f;&gt;</i> 0.05). Group RM had a lower incidence of pharyngolaryngeal pain (7.7% vs. 35.9%, <i>p</i> =&#x202f;0.003) and mucosal injury (0% vs. 15.4%, <i>p</i> =&#x202f;0.011) compared with group EI. The reduction in postoperative pain was mainly observed during the early postoperative period. In elderly patients undergoing ILMA-assisted general anesthesia, empirical inflation may result in unnecessarily high cuff pressure. Individualized cuff pressure regulation can reduce postoperative pharyngolaryngeal pain and mucosal injury without compromising ventilation seal integrity, and may represent a feasible strategy to optimize ILMA management in elderly patients. ClinicalTrials.gov, identifier NCT06954857.