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

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.

Conditions

• Supraglottic Airway Devices Position

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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Zhejiang Chinese Medical University

  collaborator OTHER

• Red Cross Hospital, Hangzhou, China

  collaborator OTHER

• Hangzhou Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Lanxi People's Hospital

  collaborator OTHER

• Ningbo Medical Center Lihuili Hospital

  collaborator OTHER_GOV

• The Second Affiliated Hospital of Jiaxing University

  collaborator OTHER

• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• The Central Hospital of Lishui City

  collaborator OTHER

• Lishui Country People's Hospital

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• First Affiliated Hospital of Zhejiang University

  lead OTHER

Principal Investigators

• Xiangming Fang · Zhejiang University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-18

Primary Completion

2027-07-31

Completion

2027-07-31

Countries

• China

Study Locations