Tulip-shaped vs. classic gel supraglottic airway device on hypopharyngeal secretion pH: a randomised clinical trial
Yonghui Wang, Kaili Qu, Xiaoshuang Tuo, Fahan Wang, Yingying Wang, Yunfei Qi, Zhihong LuAbstract
Objectives
Risk of regurgitation is an inherent limitation of supraglottic airway devices (SADs). This study aims to determine whether tulip-shaped gel SAD could affect hypopharyngeal secretion pH which may reflect risk of regurgitation.
Methods
This single-blind, randomised clinical trial was conducted from August 2024 to January 2025 at two hospitals in China. Patients aged over 18 years and scheduled for elective surgery were randomised to receive either tulip-shaped (GMA-Tulip) or classic gel SAD (i-gel). The primary outcome was the pH value of secretion at the tip of the SAD upon removal.
Results
A total of 72 patients were randomly assigned. The mITT analysis showed that the primary outcome was comparable between the Tulip and the Classic group (mean [SD]: 6.8 [0.7] vs. 6.9 [0.7], MD [95 % CI]: −0.04 [−0.37, 0.30]; p=0.830). No episode of gastrooesophageal reflux was observed in either group. Secondary observations suggested potentially shorter time to effective ventilation (23.0 [10.7] sec vs. 49.2 [64.8] sec; p=0.022) and fewer insertion attempts (1 [0] vs. 1 [0.75], p=0.026) with the Tulip device, but these findings are exploratory.