Anesthesia
Conditions
Keywords
general anesthesia, glottis mask airway, Tulip shaped tip, gastroesophageal reflux
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.
Interventions
DEVICEglottis mask airway
the glottis mask airway is used for maintaining ventilation during general anesthesia
OTHERtulip shaped
the tulip shaped mask airway is with a tulip shaped tip
OTHERclassical shaped
the classical shaped mask airway is with a water-drop shaped tip
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pH value of secretion on the tip of glottis mask airway at the end of surgery | at the end of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 participants with a pH value of secretion on the tip of glottis mask airway less than 4.1 | at the end of surgery | — |
| 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 |
| 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 | 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 |
| 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 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 | — |
Countries
China
Outcome results
None listed