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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Supraglottic Airway Devices Position
• Intervention / Treatment: Device: Inflatable Laryngeal Mask Airway; Device: GMA Laryngeal Mask Airway

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 1384
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiangming Fang, Doctor; Phone Number: 8613867161019; Email: xmfang@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • the First Affiliated Hospital, School of Medicine, Zhejiang University
      • Principal Investigator: Xiangming Fang, M.D.
      • Contact: Bingduo Wang, M.D.; Phone Number: 8615067607819; Email: 1323183@zju.edu.cn
      • Contact: Xiaoxia An, M.D.; Phone Number: 8613858180512; Email: anxxls@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Inflatable LMA Group; 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.	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.; Other Names: Cuffed Supraglottic Airway
Experimental: GMA Group; 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.	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.; Other Names: GMA-Tulip LMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	During LMA placement (immediately after insertion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intraoperative period (from LMA insertion until removal at end of surgery)
First-attempt success rate of LMA	First-attempt success: Successful placement of the laryngeal mask airway on the first attempt without requiring reinsertion	during procedure
Time to Successful Placement of LMA	Duration (in seconds) from LMA insertion into the oral cavity until final correct positioning is achieved	during procedure
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).	Intraoperative period
Oxygenation Stability (Intraoperative)	Peripheral oxygen saturation (SpO₂) (%) measured by continuous pulse oximetry	From patient entry into operating room to the time for LMA removal
Ventilation Parameters (Intraoperative)	The measurement of Peak Airway Pressure (Ppeak) in cmH₂O is typically obtained through real-time monitoring by the anesthesia machine's ventilator system.	from the start of mechanical ventilation after LMA placement to LMA removal
Feasibility of gastric tube insertion through LMA	Success rate: Proportion of cases with successful gastric tube placement	During LMA placement (after confirmation of correct LMA position).
LMA-Related Complications	Immediate complications: Visible blood on removal (graded: none/mild/moderate/severe), sore throat , hoarseness, aspiration. Pain assessment: NRS for sore throat .	Day 0
Patient Tolerance Score	Grade I (Excellent Tolerance) to Grade IV (Severe Intolerance)	Within 60 minutes after LMA removal
Anesthesiologist Satisfaction Survey	Scale: 1-10 (1 = Very dissatisfied, 10 = Very satisfied)	Within 30 minutes after surgery completion
Surgeon Satisfaction Assessment	Scale: 1-10 (1 = Very dissatisfied, 10 = Very satisfied)	Within 30 minutes after surgery completion
Patient Satisfaction Survey	Scale: 1-10 (1 = Very uncomfortable, 10 = Very comfortable)	Within 24 hours after surgery
Ultrasonographic Assessment of Gastric Antrum Cross-Sectional Area (CSA) in Supine Position for Monitoring Gastric Insufflation	This protocol utilizes point-of-care ultrasound (POCUS) to measure gastric antrum cross-sectional area (CSA) in supine patients, evaluating the risk of perioperative gastric insufflation caused by LMA.	Baseline: Within 10 minutes before anesthesia induction; Post-intervention: Within 3 minutes after successful LMA placement; Postoperative: After surgical closure but before LMA removal

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Collaborators: Ningbo Medical Center Lihuili Hospital; Ruijin Hospital; Sir Run Run Shaw Hospital; Red Cross Hospital, Hangzhou, China; The Central Hospital of Lishui City; Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University; The Second Affiliated Hospital of Jiaxing University; Lishui Country People's Hospital; Hangzhou Hospital of Traditional Chinese Medicine; The Second Affiliated Hospital of Zhejiang Chinese Medical University; Lanxi People's Hospital
• Investigators: Principal Investigator: Xiangming Fang, Zhejiang University

Publications and helpful links

General Publications

• Zheng J, Du L, Wang J, Zhang L, Chen G. Prewarming i-gel laryngeal mask for mechanical ventilation: a meta-analysis of randomised control trials and trial sequential analysis. BMJ Open. 2021 Aug 10;11(8):e045461. doi: 10.1136/bmjopen-2020-045461.
• Luo K, Chen K, Li Y, Ji Y. Clinical evaluation of laryngeal mask airways in video-assisted thoracic surgery: a meta-analysis of randomized controlled trials. J Cardiothorac Surg. 2024 Jun 24;19(1):361. doi: 10.1186/s13019-024-02840-6.
• Xu K, Zhang Y, Cui Y, Tian F. Patient-reported outcomes of laryngeal mask anesthesia in thoracoscopic pulmonary wedge resection: A randomized controlled study. Thorac Cancer. 2022 Nov;13(22):3192-3199. doi: 10.1111/1759-7714.14675. Epub 2022 Sep 30.
• De Rosa S, Messina A, Sorbello M, Rigobello A, Colombo D, Piccolo A, Bonaldi E, Gennaro P, Urukalo V, Pellizzari A, Bonato R, Carboni SC. Laryngeal Mask Airway Supreme vs. the Spritztube tracheal cannula in anaesthetised adult patients: A randomised controlled trial. Eur J Anaesthesiol. 2019 Dec;36(12):955-962. doi: 10.1097/EJA.0000000000001106.
• Wei CF, Chung YT. Laryngeal mask airway facilitates a safe and smooth emergence from anesthesia in patients undergoing craniotomy: a prospective randomized controlled study. BMC Anesthesiol. 2023 Jan 17;23(1):29. doi: 10.1186/s12871-023-01972-x.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: August 29, 2025
• First Submitted That Met QC Criteria: September 16, 2025
• First Posted (Actual): September 17, 2025

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: laryngeal mask; supraglottic airway device
• Other Study ID Numbers: Laryngeal mask

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared to protect participant confidentiality per institutional policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No