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RECRUITING
NCT07177586
NA

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

Sponsor: First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1384

Start Date

2025-09-18

Completion Date

2027-07-31

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

DEVICE

GMA 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.

DEVICE

Inflatable 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