Mechanical Ventilation
Conditions
Keywords
I-gel, Laryngeal mask airway protector
Brief summary
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.
Interventions
DEVICEI-gel
After the induction of anesthesia, i-gel is inserted along the palatopharyngeal curve.
DEVICELaryngeal mask airway protector
After the inudction of anesthesia, laryngeal mask airway protector is inserted along the palatopharyngeal curve, and the cuff is inflated.
Sponsors
SMG-SNU Boramae Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Requirement for mechanical ventilation under general anesthesia
Exclusion criteria
* Surgical position other than supine position * Tumors or anatomical abnormalities in the upper airway * Known or predicted difficult airway * Body mass index \> 30 kg/m2 * Required postoperative mechanical ventilation * Head and neck surgery * Aspiration tendency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oropharyngeal airway leak pressure | At 5 min after the insertion of i-gel or LMA protector | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insertion time | During the insertion of i-gel or LMA protector | 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). |
| Ease of insertion | During the insertion of i-gel or LMA protector | Ease of insertion is defined as follows. Easy: requiring no additional maneuver, fair: requiring 1 additional maneuver, difficult: requiring more than 1 additional maneuver. |
| Ease of gastric tube insertion | At 25 min after the insertion of i-gel or LMA protector | Ease of garstic tube insertion is assessed as follows; easy, difficult, impossible. |
| Number of insertion attempt for the successful placement | During the insertion of i-gel or LMA protector | The numbers of insertion attempt for successful placement are counted. |
| Blood staining on the i-gel or LMA protector | Immediately after removal of i-gel or LMA protector | After removal of the device, the presence of blood staining on the device is checked. |
| The incidence and severity of postoperative sore throat | At 1 and 24 h after surgery | Postoperative sore throat is assessed using a numerical rating scale (0-100 point). |
| The accuracy of insertion location of the device in the oropharyngeal space | At 15 min after the insertion of i-gel or LMA protector | 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. |
Countries
South Korea
Outcome results
None listed