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

Zhejiang University

Status: Enrolling

Conditions: Supraglottic Airway Devices Position

Treatments: Device: GMA Laryngeal Mask Airway; Device: Inflatable Laryngeal Mask Airway

Study type: Interventional

Funder types: Other

Identifiers

NCT07177586

Laryngeal mask

Details and patient eligibility

About

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.

Full description

Eligible patients meeting the inclusion criteria were enrolled in the study and randomly assigned into two groups using a random number table: the traditional Inflatable Laryngeal Mask Airway Group (Group L) and the GMA Group (Group G). One day before surgery, the research team conducted preliminary screening of patients scheduled for elective surgery, followed by a preoperative visit to explain the study's purpose, anesthesia considerations, and obtain informed consent. Upon entering the operating room, standard monitoring (ECG, blood pressure, pulse oximetry, etc.) was applied. The research team recorded the patient's actual fasting duration, last intake (food/liquid type), and baseline characteristics, including age, sex, height, weight, BMI, comorbidities, ASA classification, surgical type, and preoperative anxiety level. Airway assessment was reconfirmed. Anesthesia induction was performed with intravenous etomidate, vecuronium, and sufentanil. After loss of consciousness and disappearance of the eyelash reflex, manual ventilation was initiated. Following induction, the laryngeal mask was inserted.

Enrollment: 1,384 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,384 participants in 2 patient groups

Inflatable LMA Group

Active Comparator group

Description:

Patients in this group will receive airway management using the standard inflatable LMA (Laryngeal Mask Airway) during general anesthesia. The device will be inserted according to manufacturer guidelines, and sealing pressure, insertion success rate, and ventilation efficacy will be recorded.

Treatment:

Device: Inflatable Laryngeal Mask Airway

GMA Group

Experimental group

Description:

Patients in this group will receive airway management using the GMA-Tulip LMA, a modified supraglottic airway device. Insertion technique and outcome measurements (e.g., sealing pressure, ventilation parameters) will be recorded.

Treatment:

Device: GMA Laryngeal Mask Airway