Not Yet RecruitingNot Applicable

Optimizing Third-Generation Video Laryngeal Mask Position: SaCoVLM™ vs. Fiberoptic Bronchoscope

Taiwan40 participantsStarted 2025-01-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

correlation of native camera image of SaCoVLM and traditional fiberoptic endoscopy image

Timeframe: From enrollment to postoperative day 1

Trial details

NCT IDNCT06750926

SponsorKaohsiung Medical University Chung-Ho Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-31

Contact for this trial

Po-Yang Chen, MD

886-7-3121101 t38026641102@gmail.com

View on ClinicalTrials.gov More Supraglottic Airway Device trials