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

NCT07177586 | Recruiting

• 1 other identifier: Laryngeal mask
• Study Type: interventional
• Target: 1,384
• Locations: 1 country
• Sites: 1

Brief 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 clinical practice. Participation involves standard anesthesia procedures with close monitoring to ensure patient safety.

Conditions

Supraglottic Airway Devices Position

Keywords

supraglottic airway device; laryngeal mask

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Sealing pressure and positional stability of the GMA-Tulip versus inflatable LMA

  Intraoperative period (from LMA insertion until removal at end of surgery)

• First-attempt success rate of LMA

  during procedure

• Time to Successful Placement of LMA

  during procedure

• Hemodynamic response to LMA insertion and removal

  Intraoperative period

• Oxygenation Stability (Intraoperative)

  From patient entry into operating room to the time for LMA removal

Study Arms (2)

Inflatable LMA Group

ACTIVE COMPARATOR

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

GMA Group

EXPERIMENTAL

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

Interventions

GMA Laryngeal Mask Airway DEVICE

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.

Also known as: GMA-Tulip LMA

GMA Group

Inflatable Laryngeal Mask Airway DEVICE

The comparator is a conventional inflatable Laryngeal Mask Airway (LMA) of appropriate size (selected by weight/height), inserted using standard clinical protocols.

Also known as: Cuffed Supraglottic Airway

Inflatable LMA Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years;
• ASA physical status I-II;
• Strict compliance with ASA fasting guidelines;
• Normal airway anatomy;
• Voluntary participation with signed informed consent.

You may not qualify if:

• Pre-existing aspiration risk or gastrointestinal disorders;
• Oropharyngeal/laryngeal abnormalities;
• Anticipated difficult airway (≥1 of the following):
• BMI \>30 kg/m² Mouth opening \<3 cm Mallampati class III-IV Restricted neck mobility
• Contraindications to LMA use;
• Communication or cognitive impairments;

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Sir Run Run Shaw Hospital: collaborator
• 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

Study Sites (1)

The First affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 34376440 BACKGROUND

• 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.

  PMID: 38915035 BACKGROUND

• 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.

  PMID: 36178200 RESULT

• 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.

  PMID: 31644512 RESULT

• 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.

  PMID: 36650435 RESULT

Study Officials

• Xiangming Fang

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangming Fang, Doctor

CONTACT

8613867161019; xmfang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 17, 2025
• Study Start: September 18, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)