Risk of Gastric Reflux During Tulip vs GMA(Glottis Mask Airway) Airway
NCT Number: NCT06527352
Acronym: TUGGER
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anesthesia
Interventions: DEVICE: glottis mask airway|OTHER: tulip shaped|OTHER: classical shaped
Sponsor: Air Force Military Medical University, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2024-10-05
Locations: Xijing Hospital, Air Force Medical University, Xi'an, Shaanxi, 710032, China

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. 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.

Primary Outcome Measures: pH value of secretion on the tip of glottis mask airway at the end of surgery, at the end of surgery
Secondary Outcome Measures: number of participants with a pH value of secretion on the tip of glottis mask airway less than 4.1, 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, from insertion of glottis mask airway to start of surgery, at an average of 10 minutes|duration of inserting glottis mask airway, 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, from taking of glottis mask airway to inserting it to appropriate position, at an average of 1 minute|duration of establishing appropriate ventilation, from taking of glottis mask airway to inserting it to appropriate position, at an average of 1 minute|incidence of epiglottis suppression, 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, 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, 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, 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, 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, 24 hours after surgery