Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07177586

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

Led by First Affiliated Hospital of Zhejiang University · Updated on 2026-02-04

1384

Participants Needed

1

Research Sites

97 weeks

Total Duration

On this page

Sponsors

F

First Affiliated Hospital of Zhejiang University

Lead Sponsor

T

The Second Affiliated Hospital of Zhejiang Chinese Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 75 years
  • ASA physical status I or II
  • Strict compliance with ASA fasting guidelines
  • Normal airway anatomy
  • Voluntary participation with signed informed consent
Not Eligible

You will not qualify if you...

  • Pre-existing aspiration risk or gastrointestinal disorders
  • Oropharyngeal or laryngeal abnormalities
  • Anticipated difficult airway including any of: BMI over 30 kg/m², mouth opening less than 3 cm, Mallampati class III or IV, or restricted neck mobility
  • Contraindications to laryngeal mask airway use
  • Communication or cognitive impairments
  • Other exclusions as decided by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

X

Xiangming Fang, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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