Risk of Gastric Reflux During Tulip vs GMA(Glottis Mask Airway) Airway
- Conditions
- Anesthesia
- Interventions
- Device: glottis mask airwayOther: classical shapedOther: tulip shaped
- Registration Number
- NCT06527352
- Lead Sponsor
- Air Force Military Medical University, China
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 72
- age≥18 years old
- scheduled for surgery under general anesthesia with laryngeal mask airway
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description classical shaped mask airway glottis mask airway - tulip shaped mask airway glottis mask airway - classical shaped mask airway classical shaped - tulip shaped mask airway tulip shaped -
- Primary Outcome Measures
Name Time Method pH value of secretion on the tip of glottis mask airway at the end of surgery at the end of surgery
- Secondary Outcome Measures
Name Time Method Oropharyngeal leak pressure 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
incidence of glottis airway mask related adverse events by 24 hours after surgery 24 hours after surgery the glottis airway mask related adverse events include laryngeal pain, horse and dysphonia
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 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 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
score of satisfaction of anesthesiologist to glottis airway mask 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
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 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 duration of inserting glottis mask airway from taking of glottis mask airway to inserting it to appropriate position, at an average of 1 minute 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
Trial Locations
- Locations (1)
Xijing Hospital, Air Force Medical University
🇨🇳Xi'an, Shaanxi, China