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Investigators aim to compare two supraglottic airway devices; the i-gel and the newly developed laryngeal mask airway protector in terms of airway sealing effect, the insertion success rate, and the incidence of complications in anesthetized patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I-gel group | Active Comparator | After the induction of anesthesia, I-gel is inserted into the oropharyngeal space. |
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| LMA protector group | Experimental | After the induction of anesthesia, laryngeal mask airway protector is inserted into the oropharyngeal space. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I-gel | Device | After the induction of anesthesia, i-gel is inserted along the palatopharyngeal curve. |
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| Measure | Description | Time Frame |
|---|---|---|
| Oropharyngeal airway leak pressure | Oropharyngeal airway leak pressure is measured by closing the expiratory valve of the circle system at a fresh gas flow of 3 L/min and observing the airway pressure at equilibrium. | At 5 min after the insertion of i-gel or LMA protector |
| Measure | Description | Time Frame |
|---|---|---|
| Number of insertion attempt for the successful placement | The numbers of insertion attempt for successful placement are counted. | During the insertion of i-gel or LMA protector |
| Insertion time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Young Hwang, M.D., Ph.D. | SMG-SNU Boramae Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul Metropolitan Government Seoul National University Boramae Medical Center | Seoul | 156-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31272379 | Derived | Chang JE, Kim H, Lee JM, Min SW, Won D, Jun K, Hwang JY. A prospective, randomized comparison of the LMA-protector and i-gel in paralyzed, anesthetized patients. BMC Anesthesiol. 2019 Jul 4;19(1):118. doi: 10.1186/s12871-019-0785-8. |
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| Laryngeal mask airway protector | Device | After the inudction of anesthesia, laryngeal mask airway protector is inserted along the palatopharyngeal curve, and the cuff is inflated. |
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Insertion time is defined as the time from picking up the device to confirming successful placement (the appearance of the ETCO2 on the monitor screen).
| During the insertion of i-gel or LMA protector |
| Ease of insertion | Ease of insertion is defined as follows. Easy: requiring no additional maneuver, fair: requiring 1 additional maneuver, difficult: requiring more than 1 additional maneuver. | During the insertion of i-gel or LMA protector |
| Ease of gastric tube insertion | Ease of garstic tube insertion is assessed as follows; easy, difficult, impossible. | At 25 min after the insertion of i-gel or LMA protector |
| The accuracy of insertion location of the device in the oropharyngeal space | After insertion of the device, the insertion location is assessed using a fiberoptic bronchoscope; 4, only the vocal cords seen; 3, vocal cords and posterior part of the epiglottis seen; 2, vocal cords and anterior part of the epiglottis seen; 1, vocal cords not seen, but adequate ventilation. | At 15 min after the insertion of i-gel or LMA protector |
| Blood staining on the i-gel or LMA protector | After removal of the device, the presence of blood staining on the device is checked. | Immediately after removal of i-gel or LMA protector |
| The incidence and severity of postoperative sore throat | Postoperative sore throat is assessed using a numerical rating scale (0-100 point). | At 1 and 24 h after surgery |