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Completed

NCT Number: NCT03544749

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

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.

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Key information

Conditions

Laryngeal Mask Intubation; Difficult or Failed

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambu® AuraGain™

Device

After induction of anesthesia, Ambu® AuraGain™ will be inserted for the mechanical ventilation.

I-gel

Device

After induction of anesthesia, I-gel will be inserted for the mechanical ventilation.

Primary outcomes

  1. Oropharyngeal leak pressure

    Time frame: At an average of 30 seconds after insertion of laryngeal mask airway

    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).

Secondary outcomes

  1. Oropharyngeal leak pressure

    Time frame: At 5 minute after insertion of laryngeal mask airway

    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).

  2. The time for successful insertion of the device

    Time frame: During induction of anesthesia, an average of 60 seconds

    The total time is measured from the removal of the face mask until bilateral chest rise with the first capnogram upstroke.

  3. Success rate in first attempt

    Time frame: During induction of anesthesia, an average of 60 seconds

    Successful insertion of laryngeal mask airway in a first attempt

  4. Overall success rate

    Time frame: During induction of anesthesia, an average of 60 seconds

    Successful insertion of laryngeal mask airway in a maximum of three attempts

  5. The ease of insertion of device

    Time frame: During induction of anesthesia, an average of 60 seconds

    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)

  6. The number of attempts at insertion of device

    Time frame: During induction of anesthesia, an average of 60 seconds

    The number of attempts for successful insertion of laryngeal mask airway

  7. The ease of gastric tube placement

    Time frame: During induction of anesthesia, an average of 5 minutes

    The ease of gastric tube placement was graded on a subjective scale (1 = easy, 2 = difficult, 3 = unable to pass)

  8. The time for successful gastric tube placement

    Time frame: During induction of anesthesia, an average of 5 minutes

    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.

  9. The grade of fiberoptic bronchoscopic view

    Time frame: During induction of anesthesia, an average of 5 minutes

    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.

  10. Peak inspiratory pressure

    Time frame: At 5 minute after insertion of laryngeal mask airway

    Peak inspiratory pressure is recorded from mechanical ventilator.

  11. The number of airway maneuvers required to maintain airway patency

    Time frame: During the surgery, an average of 2 hours after anesthesia induction

    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.

  12. The type of airway maneuvers required to maintain airway patency

    Time frame: During the surgery, an average of 2 hours after anesthesia induction

    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.

  13. Intraoperative complications

    Time frame: During the surgery, an average of 2 hours after anesthesia induction

    Intraoperative complications including coughing, laryngospasm, bronchospasm, hypoxia (SpO2 < 90%), regurgitation, aspiration, blood staining of the device.

  14. Postoperative complications

    Time frame: An average of 2 hours after extubation

    Postoperative complications including sore throat, hoarseness/dysphonia, jaw, neck or ear pain, persistent cough, tachypnea, stridor, hypoxia (SpO2 < 90%), nausea and vomiting.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2018
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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