The supraglottic airway device(SAD), as an alternative to the endotracheal tube is inserted into the oral cavity and seals the upper esophagus and the surrounding tissue, effectively securing airway. SAD has evolved in recent years to increase efficiency and secure safety. The recently developed Ambu® AuraGain™ is a second-generation SAD with a built-in gastric port and is designed to be fitted well in the larynx and oral cavity after insertion because the shaft is bent at an angle of 90 degrees and has an inflatable cuff. In a previous study, Ambu® AuraGain™ showed a higher sealing pressure and better fibreoptic finding compared to LMA Supreme in laparoscopic surgery. On the other hand, I-gel and Ambu® AuraGain™, both of the second-generation SAD, show comparatively excellent performance according to the results of previous studies. However, there are no studies comparing the characteristics of two airway devices in adults. The purpose of this study is to compare the performance of I-gel and Ambu® AuraGain™ to make a difficult airway-like situation using cervical collar for adult patients receiving mechanical ventilation under general anesthesia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
104
After induction of anesthesia, Ambu® AuraGain™ will be inserted for the mechanical ventilation.
After induction of anesthesia, I-gel will be inserted for the mechanical ventilation.
Seoul National University Hospital
Seoul, South Korea
Oropharyngeal leak pressure
Oropharyngeal leak pressure is measured by closing the expiratory valve and administering fresh gas flow of 6 L/min, until the equilibrium pressure is reached (to a maximum of 40 cm of H2O).
Time frame: At an average of 30 seconds after insertion of laryngeal mask airway
Oropharyngeal leak pressure
Oropharyngeal leak pressure is measured by closing the expiratory valve and administering fresh gas flow of 6 L/min, until the equilibrium pressure is reached (to a maximum of 40 cm of H2O).
Time frame: At 5 minute after insertion of laryngeal mask airway
The time for successful insertion of the device
The total time is measured from the removal of the face mask until bilateral chest rise with the first capnogram upstroke.
Time frame: During induction of anesthesia, an average of 60 seconds
Success rate in first attempt
Successful insertion of laryngeal mask airway in a first attempt
Time frame: During induction of anesthesia, an average of 60 seconds
Overall success rate
Successful insertion of laryngeal mask airway in a maximum of three attempts
Time frame: During induction of anesthesia, an average of 60 seconds
The ease of insertion of device
The ease of placement was assessed using a subjective scale of 1-4 (1= no resistance, 2 = moderate resistance, 3 = high resistance, 4 = inability to place the device)
Time frame: During induction of anesthesia, an average of 60 seconds
The number of attempts at insertion of device
The number of attempts for successful insertion of laryngeal mask airway
Time frame: During induction of anesthesia, an average of 60 seconds
The ease of gastric tube placement
The ease of gastric tube placement was graded on a subjective scale (1 = easy, 2 = difficult, 3 = unable to pass)
Time frame: During induction of anesthesia, an average of 5 minutes
The time for successful gastric tube placement
The insertion time is measured from first handling of the gastric tube to confirmation of its position in the stomach by aspiration of gastric fluid.
Time frame: During induction of anesthesia, an average of 5 minutes
The grade of fiberoptic bronchoscopic view
The fiberoptic bronchoscopic view is defined as Grade 1, larynx only seen; Grade 2, larynx and epiglottis posterior surface seen; Grade 3, larynx, and epiglottis tip or anterior surface seen-visual obstruction of epiglottis to larynx: \< 50%; Grade 4, epiglottis down-folded, and its anterior surface seen-visual obstruction of epiglottis to larynx: \> 50%; Grade 5, epiglottis downfolded and larynx cannot be seen directly.
Time frame: During induction of anesthesia, an average of 5 minutes
Peak inspiratory pressure
Peak inspiratory pressure is recorded from mechanical ventilator.
Time frame: At 5 minute after insertion of laryngeal mask airway
The number of airway maneuvers required to maintain airway patency
Airway maneuvers required to maintain airway patency, including jaw thrust, head/neck extension and/or device adjustments such as advancement/withdrawal of device, and alterations to cuff volume.
Time frame: During the surgery, an average of 2 hours after anesthesia induction
The type of airway maneuvers required to maintain airway patency
Airway maneuvers required to maintain airway patency, including jaw thrust, head/neck extension and/or device adjustments such as advancement/withdrawal of device, and alterations to cuff volume.
Time frame: During the surgery, an average of 2 hours after anesthesia induction
Intraoperative complications
Intraoperative complications including coughing, laryngospasm, bronchospasm, hypoxia (SpO2 \< 90%), regurgitation, aspiration, blood staining of the device.
Time frame: During the surgery, an average of 2 hours after anesthesia induction
Postoperative complications
Postoperative complications including sore throat, hoarseness/dysphonia, jaw, neck or ear pain, persistent cough, tachypnea, stridor, hypoxia (SpO2 \< 90%), nausea and vomiting.
Time frame: An average of 2 hours after extubation
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