About this trial
A comparison of SaCo VLMTM video laryngeal mask airway with the I-gel supraglottic airway during airway management in patients undergoing elective surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ASA classification I~III, age 18~65 y/o, BMI 18~30kg/m2, elective surgery, surgery duration < 2 hours, supine position, general anesthesia with laryngeal mask airway insertion
Disqualifiers
Smoking, betel nuts use, any known anatomical variation or disease of facial or airway structure, anticipated difficult airway, limited mouth opening distance or neck motility, loosening teeth, gastroesophageal reflux history, ongoing upper airway infection or inflammation symptoms
Trial design
Parallel
Treatments tested in this trial
a native video image system
DeviceThe visualization of the glottic structures through the SaCoVLM™ imaging system is graded as follows: Grade1: Visibility of the lateral portion of the right epiglottic fold and part of the laryngeal inlet. Grade 2: Visibility of both epiglottic folds and part of the laryngeal inlet. Grade 3: Visibility of the laryngeal inlet and part of the vocal cords. Grade 4: Visibility of the entire vocal cords.
Fiberoptic bronchoscope
DeviceThe position of the i-Gel is checked using a fiberoptic endoscope
Treatment groups
Trial outcomes
Primary outcomes
glottic visualization grades by fiberoptic exam assessment
Grade 1: vocal cords were not visualizedGrade 2: vocal cords and anterior epiglottis were visualizedGrade 3: vocal cords and posterior epiglottis were visualized Grade 4: vocal cords only were visualized
Secondary outcomes
Intra-operative effectiveness
Secondary outcomes were evaluated by oropharyngeal sealing pressure, first attempt success rate, insertion time
Locations
Sponsors and contacts
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