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Peer-reviewedCC BYOpen Medicine

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

  • Yonghui Wang1
  • Kaili Qu1
  • Xiaoshuang Tuo1
  • Fahan Wang1
  • Yingying Wang1
  • Yunfei Qi2
  • Zhihong Lu1
  1. 1Department of Anaesthesiology and Perioperative Medicine, Key Laboratory of Anaesthesiology of Ministry of Education, Shaanxi Provincial Key Laboratory of Traditional Chinese Medicine, Xijing Hospital, Fourth Military Medical University, Xi’an, Shaanxi, China
  2. 2Department of Anaesthesiology, 949 Hospital, Altay, Xinjiang, China
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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.

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Cite

BibTeXRIS
BibTeX
@article{wang2026tulipshaped,
  title = {{Tulip-shaped vs. classic gel supraglottic airway device on hypopharyngeal secretion pH: a randomised clinical trial}},
  author = {Yonghui Wang and Kaili Qu and Xiaoshuang Tuo and Fahan Wang and Yingying Wang and Yunfei Qi and Zhihong Lu},
  journal = {Open Medicine},
  year = {2026},
  month = nov,
  doi = {10.1515/med-2026-1535},
  url = {https://europepmc.org/article/PMC/PMC13726525},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Tulip-shaped vs. classic gel supraglottic airway device on hypopharyngeal secretion pH: a randomised clinical trial
AU  - Yonghui Wang
AU  - Kaili Qu
AU  - Xiaoshuang Tuo
AU  - Fahan Wang
AU  - Yingying Wang
AU  - Yunfei Qi
AU  - Zhihong Lu
PY  - 2026
DA  - 2026/11/02
JO  - Open Medicine
DO  - 10.1515/med-2026-1535
UR  - https://europepmc.org/article/PMC/PMC13726525
AB  - 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.
SN  - 1911-2092
SN  - 2391-5463
ER  -