A Comparison of Ambu® AuraGain™ Laryngeal Mask Airway and I-gel in Adult

Intubation; Difficult or Failed Clinical Trial

Official title:

A Randomized Comparison of Ambu® AuraGain™ Laryngeal Mask Airway and I-gel in Patients With Simulated Cervical Immobilization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03544749
• Other study ID #: 1803-124-932
• Status: Completed
• Phase: N/A
• Start date: June 7, 2018
• Est. completion date: October 12, 2018

Study information

• Verified date: July 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 12, 2018
• Est. primary completion date: September 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients who are undergoing surgery under general anesthesia where supraglottic airway management will be appropriate.

Exclusion Criteria:

• Body mass index > 35 kg/m2

• High risk of regurgitation (hiatus hernia, gastro-esophageal reflux disease, non-fasting status)

• Criteria for difficult airway

• Patients with cervical disease or previous cervical spine surgery

Related Conditions & MeSH terms

• Intubation; Difficult or Failed
• Laryngeal Mask

Intervention

Device:
• Ambu® AuraGain™
After induction of anesthesia, Ambu® AuraGain™ will be inserted for the mechanical ventilation.
• I-gel
After induction of anesthesia, I-gel will be inserted for the mechanical ventilation.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	At an average of 30 seconds after insertion of laryngeal mask airway
Secondary	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).	At 5 minute after insertion of laryngeal mask airway
Secondary	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.	During induction of anesthesia, an average of 60 seconds
Secondary	Success rate in first attempt	Successful insertion of laryngeal mask airway in a first attempt	During induction of anesthesia, an average of 60 seconds
Secondary	Overall success rate	Successful insertion of laryngeal mask airway in a maximum of three attempts	During induction of anesthesia, an average of 60 seconds
Secondary	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)	During induction of anesthesia, an average of 60 seconds
Secondary	The number of attempts at insertion of device	The number of attempts for successful insertion of laryngeal mask airway	During induction of anesthesia, an average of 60 seconds
Secondary	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)	During induction of anesthesia, an average of 5 minutes
Secondary	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.	During induction of anesthesia, an average of 5 minutes
Secondary	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.	During induction of anesthesia, an average of 5 minutes
Secondary	Peak inspiratory pressure	Peak inspiratory pressure is recorded from mechanical ventilator.	At 5 minute after insertion of laryngeal mask airway
Secondary	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.	During the surgery, an average of 2 hours after anesthesia induction
Secondary	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.	During the surgery, an average of 2 hours after anesthesia induction
Secondary	Intraoperative complications	Intraoperative complications including coughing, laryngospasm, bronchospasm, hypoxia (SpO2 < 90%), regurgitation, aspiration, blood staining of the device.	During the surgery, an average of 2 hours after anesthesia induction
Secondary	Postoperative complications	Postoperative complications including sore throat, hoarseness/dysphonia, jaw, neck or ear pain, persistent cough, tachypnea, stridor, hypoxia (SpO2 < 90%), nausea and vomiting.	An average of 2 hours after extubation