About this trial
This study aims to compare the effectiveness of SaCoVLM™ in artificial airway ventilation during general anesthesia, focusing on the correlation between native video camera imaging and fiberoptic endoscopy. Primary outcomes include the analysis of imaging correlation, while secondary outcomes assess initial placement success rates, difficulty, blood clot adherence, vital sign changes, and postoperative complications.
Eligibility criteria
This trial accepts 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
Single group
Treatments tested in this trial
video image through laryngeal mask specific channel
Diagnostic testpatients placed SaCoVLM will be checked the proper position of placement by native camera through specific video channel and fiberoptic endoscopy through ventilation channel perspectively
Treatment groups
Trial outcomes
Primary outcomes
correlation of native camera image of SaCoVLM and traditional fiberoptic endoscopy image
The primary outcome is the analysis of the correlation between the two types of imaging, native camera image of SaCoVLM and traditional fiberoptic endoscopy image, to confirm proper position of laryngeal mask placement.
Secondary outcomes
the success rate and difficulty of initial placement of the SaCoVLM™
One of the secondary outcomes is the success rate and difficulty of initial placement of the SaCoVLM™. We will record the number of attempts to place or adjust the laryngeal mask to proper position.
whether visible blood clots adhere to the device upon removal
One of the secondary outcomes is whether visible blood clots adhere to the device upon removal.
changes in heart rate values before and after SaCoVLM placement
One of the secondary outcomes is changes in heart rate values before and after SaCoVLM placement.
changes in mean arterial blood pressure values before and after SaCoVLM placement
One of the secondary outcomes is changes in mean arterial blood pressure values before and after SaCoVLM placement.
Sponsors and contacts
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