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Supraglottic Airway Devices PositionNCT07177586

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

A study testing GMA Laryngeal Mask Airway and Inflatable Laryngeal Mask Airway in people with Supraglottic Airway Devices Position, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Supraglottic Airway Devices Position
What is being tested?
GMA Laryngeal Mask Airway and Inflatable Laryngeal Mask Airway
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,384 participants
Where
1 siteChina
Study dates
18 Sep 2025to 31 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiangming Fang, Doctor contact

8613867161019

xmfang@zju.edu.cn

China1 site, 1 recruiting

  • The First affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310000

    Bingduo Wang, M.D., 8615067607819, 1323183@zju.edu.cn

    Xiaoxia An, M.D., 8613858180512, anxxls@163.com

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
GMA Laryngeal Mask Airway, Inflatable Laryngeal Mask Airway
Keywords
supraglottic airway device, laryngeal mask

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GMA Laryngeal Mask AirwayDevice

    Also called GMA-Tulip LMA

    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.

  • Inflatable Laryngeal Mask AirwayDevice

    Also called Cuffed Supraglottic Airway

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

Study groups in NCT07177586
Study groupRoleWhat they receive
Inflatable LMA GroupActive comparatorPatients 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.
Receives: Device: Inflatable Laryngeal Mask Airway
GMA GroupExperimentalPatients 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.
Receives: Device: GMA Laryngeal Mask Airway

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: During LMA placement (immediately after insertion)

Secondary outcomes (13)

  1. 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.

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

  2. First-attempt success rate of LMA

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

    Measured: during procedure

  3. Time to Successful Placement of LMA

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

    Measured: during procedure

  4. 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).

    Measured: Intraoperative period

  5. Oxygenation Stability (Intraoperative)

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

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

  6. 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.

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

  7. Feasibility of gastric tube insertion through LMA

    Success rate: Proportion of cases with successful gastric tube placement

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

  8. LMA-Related Complications

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

    Pain assessment: NRS for sore throat .

    Measured: Day 0

  9. Patient Tolerance Score

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

    Measured: Within 60 minutes after LMA removal

  10. Anesthesiologist Satisfaction Survey

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

    Measured: Within 30 minutes after surgery completion

  11. Surgeon Satisfaction Assessment

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

    Measured: Within 30 minutes after surgery completion

  12. Patient Satisfaction Survey

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

    Measured: Within 24 hours after surgery

  13. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2025
  2. Study start18 Sep 2025
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,384 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07177586
Sponsor's protocol ID
Laryngeal mask
Status last verified
Feb 2026
First submitted
29 Aug 2025
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared to protect participant confidentiality per institutional policies.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 36650435

Questions about this trial

What is this clinical trial studying?

A study testing GMA Laryngeal Mask Airway and Inflatable Laryngeal Mask Airway in people with Supraglottic Airway Devices Position, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiangming Fang, Doctor (8613867161019, xmfang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate of anatomical alignment of laryngeal mask (time frame: During LMA placement (immediately after insertion)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07177586, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.

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