Status:

RECRUITING

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

Lead Sponsor:

First Affiliated Hospital of Zhejiang University

Collaborating Sponsors:

The Second Affiliated Hospital of Zhejiang Chinese Medical University

Red Cross Hospital, Hangzhou, China

Conditions:

Supraglottic Airway Devices Position

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief 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 objectiv...

Detailed Description

Eligible patients meeting the inclusion criteria were enrolled in the study and randomly assigned into two groups using a random number table: the traditional Inflatable Laryngeal Mask Airway Group (G...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • 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

  • 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

Key Trial Info

Start Date :

September 18 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 31 2026

Estimated Enrollment :

1384 Patients enrolled

Trial Details

Trial ID

NCT07177586

Start Date

September 18 2025

End Date

January 31 2026

Last Update

December 22 2025

Active Locations (1)

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1

The First affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China, 310000