Menu
Recruiting NCT07177586

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

No phase Interventional Supraglottic Airway Devices Position

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GMA Laryngeal Mask Airway, Inflatable Laryngeal Mask Airway.
Who it may be relevant to
Registry conditions: Supraglottic Airway Devices Position. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Success rate of anatomical alignment of laryngeal mask [Time frame: During LMA placement (immediately after insertion)]
Secondary outcome measures (12)
  • Sealing pressure and positional stability of the GMA-Tulip versus inflatable LMA [Time frame: Intraoperative period (from LMA insertion until removal at end of surgery)]
  • First-attempt success rate of LMA [Time frame: during procedure]
  • Time to Successful Placement of LMA [Time frame: during procedure]
  • Hemodynamic response to LMA insertion and removal [Time frame: Intraoperative period]
  • Oxygenation Stability (Intraoperative) [Time frame: From patient entry into operating room to the time for LMA removal]
  • Ventilation Parameters (Intraoperative) [Time frame: from the start of mechanical ventilation after LMA placement to LMA removal]
  • Feasibility of gastric tube insertion through LMA [Time frame: During LMA placement (after confirmation of correct LMA position).]
  • LMA-Related Complications [Time frame: Day 0]
  • Patient Tolerance Score [Time frame: Within 60 minutes after LMA removal]
  • Anesthesiologist Satisfaction Survey [Time frame: Within 30 minutes after surgery completion]
  • Surgeon Satisfaction Assessment [Time frame: Within 30 minutes after surgery completion]
  • Patient Satisfaction Survey [Time frame: Within 24 hours after surgery]

Eligibility criteria

Inclusion criteria

  • Inclusion Criteria
  • Age 18-75 years;
  • ASA physical status I-II;
  • Strict compliance with ASA fasting guidelines;
  • Normal airway anatomy;
  • Voluntary participation with signed informed consent.
  • Exclusion Criteria:
  • 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;
  • Other exclusions at investigator's discretion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

China · 1 center
  • The First affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou

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. PMID 34376440
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07177586 · Laryngeal mask

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗