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NCT Number: NCT07177586

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Bingduo Wang, M.D.

CONTACT

[email protected]

8615067607819

Xiangming Fang, M.D.

PRINCIPAL_INVESTIGATOR

Xiaoxia An, M.D.

CONTACT

[email protected]

8613858180512

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: GMA-Tulip LMA

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.

Other names: Cuffed Supraglottic Airway

Primary outcomes

  1. Success rate of anatomical alignment of laryngeal mask

    Time frame: During LMA placement (immediately after insertion)

    Comparison of anatomical positioning success rates between inflatable LMA and GMA-Tulip LMA, assessed by fiberoptic bronchoscopy (FOB).

Secondary outcomes

  1. 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)

    Assess the stability and anti-displacement properties of special body positions (e.g. lateral decubitus, Trendelenburg position) and the laryngeal mask airway under pneumoperitoneum.

  2. First-attempt success rate of LMA

    Time frame: during procedure

    First-attempt success: Successful placement of the laryngeal mask airway on the first attempt without requiring reinsertion

  3. Time to Successful Placement of LMA

    Time frame: during procedure

    Duration (in seconds) from LMA insertion into the oral cavity until final correct positioning is achieved

  4. Hemodynamic response to LMA insertion and removal

    Time frame: Intraoperative period

    Parameters: Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) (measured non-invasively or invasively).

  5. Oxygenation Stability (Intraoperative)

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

    Peripheral oxygen saturation (SpO₂) (%) measured by continuous pulse oximetry

  6. Ventilation Parameters (Intraoperative)

    Time frame: from the start of mechanical ventilation after LMA placement to LMA removal

    The measurement of Peak Airway Pressure (Ppeak) in cmH₂O is typically obtained through real-time monitoring by the anesthesia machine's ventilator system.

  7. Feasibility of gastric tube insertion through LMA

    Time frame: During LMA placement (after confirmation of correct LMA position).

    Success rate: Proportion of cases with successful gastric tube placement

  8. LMA-Related Complications

    Time frame: Day 0

    Immediate complications: Visible blood on removal (graded: none/mild/moderate/severe), sore throat , hoarseness, aspiration.

    Pain assessment: NRS for sore throat .

  9. Patient Tolerance Score

    Time frame: Within 60 minutes after LMA removal

    Grade I (Excellent Tolerance) to Grade IV (Severe Intolerance)

  10. Anesthesiologist Satisfaction Survey

    Time frame: Within 30 minutes after surgery completion

    Scale: 1-10 (1 = Very dissatisfied, 10 = Very satisfied)

  11. Surgeon Satisfaction Assessment

    Time frame: Within 30 minutes after surgery completion

    Scale: 1-10 (1 = Very dissatisfied, 10 = Very satisfied)

  12. Patient Satisfaction Survey

    Time frame: Within 24 hours after surgery

    Scale: 1-10 (1 = Very uncomfortable, 10 = Very comfortable)

  13. Ultrasonographic Assessment of Gastric Antrum Cross-Sectional Area (CSA) in Supine Position for Monitoring Gastric Insufflation

    Time frame: Baseline: Within 10 minutes before anesthesia induction; Post-intervention: Within 3 minutes after successful LMA placement; Postoperative: After surgical closure but before LMA removal

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangming Fang, Doctor

CONTACT

[email protected]

8613867161019

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Collaborators

  • Hangzhou Hospital of Traditional Chinese Medicine
  • Lanxi People's Hospital
  • Lishui Country People's Hospital
  • Ningbo Medical Center Lihuili Hospital
  • Red Cross Hospital, Hangzhou, China
  • Ruijin Hospital
  • Sir Run Run Shaw Hospital
  • Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
  • The Central Hospital of Lishui City
  • The Second Affiliated Hospital of Jiaxing University
  • The Second Affiliated Hospital of Zhejiang Chinese Medical University

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 17, 2025
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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