Prospective Clinical Evaluation of the Singularity™ Air Laryngeal Mask in Adult Patients

Abstract

A laryngeal mask is one of the most widely used airway management devices. The SingularityTM Air is a second-generation laryngeal mask whose shaft angle can be adjusted after insertion. Since the device’s performance has been assessed on mannequins only, this study aimed to evaluate SingularityTM Air’s effectiveness in the clinical setting. The prospective single-center cohort study included 100 adults undergoing elective surgery under general anesthesia and suitable for airway securing with a laryngeal mask. The primary endpoint was the oropharyngeal leak pressure, and the secondary endpoints were the ease of insertion and the patient’s comfort. Laryngeal mask insertion was successful in 97%, and mechanical ventilation was possible in 96% of patients. After insertion, the median (IQR) oropharyngeal leak pressure was 25 (18–25) cm H2O, which remained stable at 25 (25–25) cm H2O after 20 min. The median (IQR) time for successful manual bag ventilation was 42 (34–50) seconds. Nineteen patients complained of side effects (e.g., sore throat, difficulty swallowing), but none persisted. The SingularityTM Air performed well in a clinical setting, and its oropharyngeal leak pressure was comparable to that of other masks reported in the literature. The time for successful manual ventilation was slightly longer, and patients reported more temporary side effects.