New-generation GMA versus conventional inflatable laryngeal mask for airway management during general anesthesia
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
Run by First Affiliated Hospital of Zhejiang University · NCT07177586 · Data updated 2026-11-12
This trial will test whether the new GMA laryngeal mask provides safer, more stable, and more comfortable airway management than the conventional inflatable laryngeal mask for adults having elective surgery under general anesthesia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 1384 (estimated) |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | September 18, 2025 |
| Main results expected | July 31, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | February 4, 2026 |
| Trial ID | NCT07177586 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 years with ASA physical status I–II, normal airway anatomy, and scheduled for elective surgery who can follow fasting guidelines and provide informed consent are ideal candidates.
✕Probably not a fit
Patients with anticipated difficult airways, aspiration risk, significant obesity (BMI >30), or other contraindications to laryngeal mask use are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adult patients scheduled for elective surgery are randomized to receive either the new-generation GMA laryngeal mask or a conventional inflatable laryngeal mask after standardized anesthesia induction. Preoperative screening and baseline airway assessments are performed, and insertion, positioning, sealing, stability, and patient comfort are recorded under standard monitoring in the operating room. The study compares device performance, ease of use, and safety outcomes between the two groups and analyzes anatomical positioning and sealing mechanisms to identify factors affecting alignment. Follow-up is performed during the perioperative period to capture immediate device-related outcomes.
Why it matters
Potential benefit: If successful, the GMA could improve airway stability, patient comfort, and reduce airway-related complications during general anesthesia.
How similar studies have gone: Previous comparisons of supraglottic airway devices have shown mixed results with some newer designs improving seal or ease of use, but the specific GMA device remains relatively new and less extensively studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
The First affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Principal investigator: Xiangming Fang — First Affiliated Hospital of Zhejiang University
- Study coordinator: Xiangming Fang, Doctor
- Email: xmfang@zju.edu.cn
- Phone: 8613867161019
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
LarySeal Clear versus Ambu Aura40 airway masks for preschool children
This test will see if the LarySeal Clear or the Ambu Aura40 laryngeal mask works better for keeping a secure airway in preschool children having short general anesthesia.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.