CompletedNot Applicable

The New Third Generation Video Laryngeal Mask Evaluation

Czechia50 participantsStarted 2025-06-14

Plain-language summary

The goal of this study is to evaluate the performance of the new video laryngeal masks for securing airway in patients undergoing general anaesthesia. Main goal is to evaluate the first insertion attempt success rate, time to adequate ventilation, sealing pressures and adverse events.

Who can participate

Age range

10 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 * Patient without predicted difficult airway (MACOCHA score ≤ 2), undergoing a planned surgical procedure under general anesthesia with an indication for airway management using a laryngeal mask. * Patient aged 18 years or older. Exclusion Criteria * Patient younger than 18 years. * Patient with predicted difficult airway (MACOCHA score \> 2). * Patient with a history of difficult airway. * Patient requiring airway management with a method other than a laryngeal mask. * Refusal or failure to sign the informed consent for study participation. * Patient undergoing emergency surgery. * Administration of muscle relaxants for LMA insertion. * State Entropy value below 30 during LMA insertion. * State Entropy value above 60 during LMA insertion.

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

First insertion attempt success rate

Timeframe: From the start of the attempt to the end of the general anesthesia.

Trial details

NCT IDNCT07007403

SponsorMasarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-30

View on ClinicalTrials.gov More Supraglottic Airway trials

Who can participate

Age range

10 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.