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.
Inclusion Criteria
Age 18-75 years;
ASA physical status I-II;
Strict compliance with ASA fasting guidelines;
Pre-existing aspiration risk or gastrointestinal disorders;
Oropharyngeal/laryngeal abnormalities;
Contraindications to LMA use;
Communication or cognitive impairments;
Parallel
GMA Laryngeal Mask Airway
DeviceThe 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.
Inflatable Laryngeal Mask Airway
DeviceThe comparator is a conventional inflatable Laryngeal Mask Airway (LMA) of appropriate size (selected by weight/height), inserted using standard clinical protocols.
Success rate of anatomical alignment of laryngeal mask
Comparison of anatomical positioning success rates between inflatable LMA and GMA-Tulip LMA, assessed by fiberoptic bronchoscopy (FOB).
Sealing pressure and positional stability of the GMA-Tulip versus inflatable LMA
Assess the stability and anti-displacement properties of special body positions (e.g. lateral decubitus, Trendelenburg position) and the laryngeal mask airway under pneumoperitoneum.
First-attempt success rate of LMA
First-attempt success: Successful placement of the laryngeal mask airway on the first attempt without requiring reinsertion
Time to Successful Placement of LMA
Duration (in seconds) from LMA insertion into the oral cavity until final correct positioning is achieved
Hemodynamic response to LMA insertion and removal
Parameters: Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) (measured non-invasively or invasively).
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First Affiliated Hospital of Zhejiang University
Lead sponsor
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Collaborator
Red Cross Hospital, Hangzhou, China
Collaborator
Hangzhou Hospital of Traditional Chinese Medicine
Collaborator
Lanxi People's Hospital
Collaborator
Ningbo Medical Center Lihuili Hospital
Collaborator
The Second Affiliated Hospital of Jiaxing University
Collaborator
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Collaborator
Ruijin Hospital
Collaborator
The Central Hospital of Lishui City
Collaborator
Lishui Country People's Hospital
Collaborator
Sir Run Run Shaw Hospital
Collaborator
