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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

August 1, 2024

Primary Completion (Actual)

January 28, 2025

Study Completion (Actual)

January 29, 2025

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Anesthesia

Clinical Trials on glottis mask airway

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe