Work

Tulip-shaped vs. classic gel supraglottic airway device on hypopharyngeal secretion pH: a randomised clinical trial

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: 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. Conclusions: Tulip-shaped gel SAD did not result in a significant difference in the pH of secretions at the device tip compared to i-gel. Clinical trial registration: ClinicalTrial.gov (NCT06527352), https://clinicaltrials.gov.

Source: Open Medicine

DOI: 10.1515/med-2026-1535