New-Generation GMA Laryngeal Mask Airway Versus Conventional Inflatable Laryngeal Mask Air
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 prac
| Condition(s) | Supraglottic Airway Devices Position |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 clin |
| Who can participate | Inclusion Criteria: * Inclusion Criteria 1. Age 18-75 years; 2. ASA physical status I-II; 3. Strict compliance with ASA fasting guidelines; 4. Normal airway anatomy; 5. Voluntary participation with signed informed consent. * Exclusion Criteria: 1. Pre-existing aspiration risk or gastrointestinal disorders; 2. Oropharyngeal/laryngeal abnormalities; 3. Anticipated difficult airway (≥1 of the following): BMI \>30 kg/m² Mouth opening \<3 cm Mallampati class III-IV Restricted neck mobility 4. Contraindications to LMA use; 5. Communication or cognitive impairments; 6. Other exclusions at investigator's discretion |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | First Affiliated Hospital of Zhejiang University |
| Locations | Hangzhou, Zhejiang, China |
| Start date | 2025-09-18 |
| NCT ID | NCT07177586 |
| Official listing | https://clinicaltrials.gov/study/NCT07177586 |