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

NCT ID: NCT06527352

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-01-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

classical shaped mask airway

Group Type OTHER

glottis mask airway

Intervention Type DEVICE

the glottis mask airway is used for maintaining ventilation during general anesthesia

classical shaped

Intervention Type OTHER

the classical shaped mask airway is with a water-drop shaped tip

tulip shaped mask airway

Group Type OTHER

glottis mask airway

Intervention Type DEVICE

the glottis mask airway is used for maintaining ventilation during general anesthesia

tulip shaped

Intervention Type OTHER

the tulip shaped mask airway is with a tulip shaped tip

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

glottis mask airway

the glottis mask airway is used for maintaining ventilation during general anesthesia

Intervention Type DEVICE

tulip shaped

the tulip shaped mask airway is with a tulip shaped tip

Intervention Type OTHER

classical shaped

the classical shaped mask airway is with a water-drop shaped tip

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhihong LU

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Xijing Hospital, Air Force Medical University

Xi'an, Shaanxi, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 28183569 (View on PubMed)

Nakanishi 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.

Reference Type BACKGROUND
PMID: 34182933 (View on PubMed)

Liu 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.

Reference Type RESULT
PMID: 34930137 (View on PubMed)

Bhardwaj 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.

Reference Type RESULT
PMID: 38187973 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XJH-A-20240708

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.