AnesthesiaTUGGERNCT06527352
Risk of Gastric Reflux During Tulip vs GMA(Glottis Mask Airway) Airway
A study testing glottis mask airway, tulip shaped and classical shaped in people with Anesthesia, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- glottis mask airway, tulip shaped and classical shaped
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 29 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age≥18 years old
- scheduled for surgery under general anesthesia with laryngeal mask airway
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital, Air Force Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: 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.
- Conditions
- Anesthesia
- Being tested
- glottis mask airway, tulip shaped, classical shaped
- Keywords
- general anesthesia, glottis mask airway, Tulip shaped tip, gastroesophageal reflux
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glottis mask airwayDevice
the glottis mask airway is used for maintaining ventilation during general anesthesia
tulip shapedOther
the tulip shaped mask airway is with a tulip shaped tip
classical shapedOther
the classical shaped mask airway is with a water-drop shaped tip
| Study group | Role | What they receive |
|---|---|---|
| classical shaped mask airway | Other | Not described Receives: Device: glottis mask airway; Other: classical shaped |
| tulip shaped mask airway | Other | Not described Receives: Device: glottis mask airway; Other: tulip shaped |
What is being measured
The primary outcome is the main question the study is designed to answer.
pH value of secretion on the tip of glottis mask airway at the end of surgery
Measured: at the end of surgery
Secondary outcomes (11)
number of participants with a pH value of secretion on the tip of glottis mask airway less than 4.1
Measured: at the end of surgery
Oropharyngeal leak pressure
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
Measured: from insertion of glottis mask airway to start of surgery, at an average of 10 minutes
duration of inserting glottis mask airway
Measured: 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
Measured: from taking of glottis mask airway to inserting it to appropriate position, at an average of 1 minute
duration of establishing appropriate ventilation
Measured: from taking of glottis mask airway to inserting it to appropriate position, at an average of 1 minute
incidence of epiglottis suppression
Measured: 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
Measured: from insertion of glottis mask airway to end of surgery, at an average of 2 hours
scale of difficulty of inserting gastric tube
0 is for easy to insert; 1 is for a little difficult to insert; 2 is for fail to insert
Measured: 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
Measured: 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
the score is from 0 to 10, a higher score means higher satisfaction
Measured: 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
the glottis airway mask related adverse events include laryngeal pain, horse and dysphonia
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Aug 2024
- Primary completion28 Jan 2025
- Study completion29 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong LU, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527352
- Sponsor's protocol ID
- XJH-A-20240708
- Acronym
- TUGGER
- Status last verified
- Jan 2026
- First submitted
- 25 Jul 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lemos J, De Oliveira GS Jr, de Pereira Cardoso HE, Lemos LD, de Carvalho LR, Modolo NS. Gastric regurgitation in patients undergoing gynecological laparoscopy with a laryngeal mask airway: a prospective observational study. J Clin Anesth. 2017 Feb;36:32-35. doi: 10.1016/j.jclinane.2016.07.038. Epub 2016 Nov 11.
PubMed 28183569Nakanishi T, Sakamoto S, Yoshimura M, Toriumi T. AutoFlow(R) versus volume-controlled ventilation for laparoscopic gynecological surgery using LMA(R) ProSeal: a randomized controlled trial. BMC Anesthesiol. 2021 Jun 28;21(1):181. doi: 10.1186/s12871-021-01406-6.
PubMed 34182933Liu Y, Song Y, Wang M, Yang M, Shen H, Wang Z, Chen L, Yang J, Gong S, Yu Y, Shi Z, Zhang W, Zou X, Sun X, Wang Y, Fu Q, Cao J, Mi W. LMA(R) protector in patients undergoing laparoscopic surgeries: a multicenter prospective observational study. BMC Anesthesiol. 2021 Dec 20;21(1):318. doi: 10.1186/s12871-021-01535-y.
PubMed 34930137Bhardwaj M, Dhania S, Kaur K, Lal J, Priya, Singhal SK. Comparison of oropharyngeal leak pressure of LMA Protector and LMA ProSeal in anaesthetised paralysed patients - A randomised controlled trial. Indian J Anaesth. 2023 Nov;67(Suppl 4):S245-S250. doi: 10.4103/ija.ija_403_23. Epub 2023 Nov 21.
PubMed 38187973Wang Y, Qu K, Tuo X, Wang F, Wang Y, Qi Y, Lu Z. Tulip-shaped vs. classic gel supraglottic airway device on hypopharyngeal secretion pH: a randomised clinical trial. Open Med (Wars). 2026 Nov 2;21(1):20261535. doi: 10.1515/med-2026-1535. eCollection 2026 Jan.
PubMed 42974115
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Risk of Gastroesophageal Reflux During General Anesthesia With Tulip vs GMA(Glottis Mask Airway) Airway
- ClinicalTrials.gov ID
- NCT06527352
- Acronym / sponsor ID
- TUGGER / XJH-A-20240708
- Conditions
- Anesthesia
- Keywords
- general anesthesia, glottis mask airway, Tulip shaped tip, gastroesophageal reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 28 Jan 2025 (actual)
- Study completion
- 29 Jan 2025 (actual)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| classical shaped mask airway | Other | Device: glottis mask airway, Other: classical shaped |
| tulip shaped mask airway | Other | Device: glottis mask airway, Other: tulip shaped |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age≥18 years old
- scheduled for surgery under general anesthesia with laryngeal mask airway
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glottis mask airwaythe glottis mask airway is used for maintaining ventilation during general anesthesia | Device | classical shaped mask airway, tulip shaped mask airway |
| tulip shapedthe tulip shaped mask airway is with a tulip shaped tip | Other | tulip shaped mask airway |
| classical shapedthe classical shaped mask airway is with a water-drop shaped tip | Other | classical shaped mask airway |
Primary outcome
pH value of secretion on the tip of glottis mask airway at the end of surgery
Time frame: at the end of surgery
11 secondary outcomes
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
Oropharyngeal leak pressure
Time frame: 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
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
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
incidence of epiglottis suppression
Time frame: 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
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
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
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
incidence of glottis airway mask related adverse events by 24 hours after surgery
Time frame: 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Background: PubMed 28183569Lemos J, De Oliveira GS Jr, de Pereira Cardoso HE, Lemos LD, de Carvalho LR, Modolo NS. Gastric regurgitation in patients undergoing gynecological laparoscopy with a laryngeal mask airway: a prospective observational study. J Clin Anesth. 2017 Feb;36:32-35. doi: 10.1016/j.jclinane.2016.07.038. Epub 2016 Nov 11.
- Background: PubMed 34182933Nakanishi T, Sakamoto S, Yoshimura M, Toriumi T. AutoFlow(R) versus volume-controlled ventilation for laparoscopic gynecological surgery using LMA(R) ProSeal: a randomized controlled trial. BMC Anesthesiol. 2021 Jun 28;21(1):181. doi: 10.1186/s12871-021-01406-6.
- Results publication: PubMed 34930137Liu Y, Song Y, Wang M, Yang M, Shen H, Wang Z, Chen L, Yang J, Gong S, Yu Y, Shi Z, Zhang W, Zou X, Sun X, Wang Y, Fu Q, Cao J, Mi W. LMA(R) protector in patients undergoing laparoscopic surgeries: a multicenter prospective observational study. BMC Anesthesiol. 2021 Dec 20;21(1):318. doi: 10.1186/s12871-021-01535-y.
- Results publication: PubMed 38187973Bhardwaj M, Dhania S, Kaur K, Lal J, Priya, Singhal SK. Comparison of oropharyngeal leak pressure of LMA Protector and LMA ProSeal in anaesthetised paralysed patients - A randomised controlled trial. Indian J Anaesth. 2023 Nov;67(Suppl 4):S245-S250. doi: 10.4103/ija.ija_403_23. Epub 2023 Nov 21.
- Derived from this study: PubMed 42974115Wang Y, Qu K, Tuo X, Wang F, Wang Y, Qi Y, Lu Z. Tulip-shaped vs. classic gel supraglottic airway device on hypopharyngeal secretion pH: a randomised clinical trial. Open Med (Wars). 2026 Nov 2;21(1):20261535. doi: 10.1515/med-2026-1535. eCollection 2026 Jan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glottis mask airway, tulip shaped and classical shaped in people with Anesthesia, run by Air Force Military Medical University, China 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 6 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pH value of secretion on the tip of glottis mask airway at the end of surgery (time frame: at the end of surgery). 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 NCT06527352, 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 6 Jan 2026.