Risk of Gastric Reflux During Tulip vs GMA(Glottis Mask Airway) Airway (TUGGER)

January 3, 2026 updated by: Zhihong LU, Air Force Military Medical University, China

Comparison of Risk of Gastroesophageal Reflux During General Anesthesia With Tulip vs GMA(Glottis Mask Airway) Airway

Glottis mask airway (GMA) is supraglottic airway device and is frequently used in patients undergoing general anesthesia. However, gastroesophageal reflux remains a risk during ventilation through supraglottic airway devices. The classical shaped GMA and tulip shaped GMA differ in the shape of their tips. And theoretically the tulip shaped tip fits the larynx better. This study aims to compare the incidence of gastroesophageal reflux during ventilation through classical shaped vs tulip shaped glottis mask airway.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital, Air Force Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age≥18 years old
  • scheduled for surgery under general anesthesia with laryngeal mask airway

Exclusion Criteria:

  • American society of anesthesiologists status score higher than 3
  • morbid obesity (body mass index higher than 40 kg/m2)
  • with high risk of gastroesophageal reflux
  • with risk of difficult airway
  • with airway disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: classical shaped mask airway
Device: glottis mask airway
the glottis mask airway is used for maintaining ventilation during general anesthesia
Other: classical shaped
the classical shaped mask airway is with a water-drop shaped tip
Other: tulip shaped mask airway
Device: glottis mask airway
the glottis mask airway is used for maintaining ventilation during general anesthesia
Other: tulip shaped
the tulip shaped mask airway is with a tulip shaped tip

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
pH value of secretion on the tip of glottis mask airway at the end of surgery
Time Frame: at the end of surgery
at the end of surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
number of participants with a pH value of secretion on the tip of glottis mask airway less than 4.1
Time Frame: at the end of surgery
at the end of surgery
Oropharyngeal leak pressure
Time Frame: from insertion of glottis mask airway to start of surgery, at an average of 10 minutes
Oropharyngeal leak pressure (OLP) was measured by setting the adjustable pressure limiting valve to 40 cmH2O at a fixed gas flow of 3 L/min and noting the steady-state airway pressure on the monitor
from insertion of glottis mask airway to start of surgery, at an average of 10 minutes
duration of inserting glottis mask airway
Time Frame: from taking of glottis mask airway to inserting it to appropriate position, at an average of 1 minute
from taking of glottis mask airway to inserting it to appropriate position, at an average of 1 minute
number of insertion to achieve successful positioning of glottis mask airway
Time Frame: from taking of glottis mask airway to inserting it to appropriate position, at an average of 1 minute
from taking of glottis mask airway to inserting it to appropriate position, at an average of 1 minute
duration of establishing appropriate ventilation
Time Frame: from taking of glottis mask airway to inserting it to appropriate position, at an average of 1 minute
from taking of glottis mask airway to inserting it to appropriate position, at an average of 1 minute
incidence of epiglottis suppression
Time Frame: from insertion of glottis mask airway to start of surgery, at an average of 10 minutes
from insertion of glottis mask airway to start of surgery, at an average of 10 minutes
number of needs for modulating the position of glottis airway mask during surgery
Time Frame: from insertion of glottis mask airway to end of surgery, at an average of 2 hours
from insertion of glottis mask airway to end of surgery, at an average of 2 hours
scale of difficulty of inserting gastric tube
Time Frame: from insertion of glottis mask airway to start of surgery, at an average of 10 minutes
0 is for easy to insert; 1 is for a little difficult to insert; 2 is for fail to insert
from insertion of glottis mask airway to start of surgery, at an average of 10 minutes
incidence of blood on the tip of glottis airway mask
Time Frame: from end of surgery to withdrawal of glottis airway mask, at an average of 5 minutes
from end of surgery to withdrawal of glottis airway mask, at an average of 5 minutes
score of satisfaction of anesthesiologist to glottis airway mask
Time Frame: from insertion of glottis mask airway to withdrawal of glottis airway mask, at an average of 2 hours
the score is from 0 to 10, a higher score means higher satisfaction
from insertion of glottis mask airway to withdrawal of glottis airway mask, at an average of 2 hours
incidence of glottis airway mask related adverse events by 24 hours after surgery
Time Frame: 24 hours after surgery
the glottis airway mask related adverse events include laryngeal pain, horse and dysphonia
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Air Force Military Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 28, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XJH-A-20240708

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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