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RecruitingNot ApplicableNCT07177586

New-Generation GMA Laryngeal Mask Airway Versus Conventional Inflatable Laryngeal Mask Airway

A Multicenter, Randomized Controlled Study Comparing the Effectiveness of the New Generation GMA Laryngeal Mask and Conventional Laryngeal Mask in Airway Management During General Anesthesia

Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

1,384 participants

Start Date

Sep 18, 2025

Study Type

INTERVENTIONAL

Conditions

Supraglottic Airway Devices Position

Summary

This study aims to compare the new-generation GMA laryngeal mask airway (LMA) with the traditional inflatable LMA in patients undergoing elective surgery under general anesthesia. The primary objectives are to evaluate the safety, effectiveness, stability, ease of use, and patient comfort of the GMA LMA, providing practical guidance for clinical airway management. Additionally, this research will analyze the anatomical positioning and sealing mechanism of the LMA to identify factors influencing proper alignment and airway sealing. The findings may contribute to future improvements in LMA design, enhancing patient safety and procedural success. This study is designed for healthcare providers, anesthesiologists, and researchers seeking evidence-based recommendations for LMA selection in clinical practice. Participation involves standard anesthesia procedures with close monitoring to ensure patient safety.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • Age 18-75 years;
  • ASA physical status I-II;
  • Strict compliance with ASA fasting guidelines;
  • Normal airway anatomy;
  • Voluntary participation with signed informed consent.

Exclusion Criteria7

  • Pre-existing aspiration risk or gastrointestinal disorders;
  • Oropharyngeal/laryngeal abnormalities;
  • Anticipated difficult airway (≥1 of the following):
  • BMI \>30 kg/m² Mouth opening \<3 cm Mallampati class III-IV Restricted neck mobility
  • Contraindications to LMA use;
  • Communication or cognitive impairments;
  • Other exclusions at investigator's discretion
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Interventions

DEVICEGMA Laryngeal Mask Airway

The GMA-Tulip is a new single-use supraglottic airway device (SAD). Device size is selected based on the patient's weight and height, following manufacturer guidelines.

DEVICEInflatable Laryngeal Mask Airway

The comparator is a conventional inflatable Laryngeal Mask Airway (LMA) of appropriate size (selected by weight/height), inserted using standard clinical protocols.

Locations(1)

The First affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

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NCT07177586