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Completed

NCT Number: NCT06527352

Risk of Gastric Reflux During 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.

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Key information

Conditions

Anesthesia Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital, Air Force Medical University

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glottis mask airway

Device

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

tulip shaped

Other

the tulip shaped mask airway is with a tulip shaped tip

classical shaped

Other

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

Primary outcomes

  1. pH value of secretion on the tip of glottis mask airway at the end of surgery

    Time frame: at the end of surgery

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. incidence of epiglottis suppression

    Time frame: from insertion of glottis mask airway to start of surgery, at an average of 10 minutes

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Acronym: TUGGER

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2024
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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