CompletedNot Applicable

A Comparison of the I-gel and the Self-pressurised Air-Q Intubating Laryngeal Airway in Children

South Korea80 participantsStarted 2014-05

Plain-language summary

Supraglottic airway devices (SADs) are well established in pediatric anesthetic practice. The pediatric i-gel and the self-pressurised air-Q (air-Q) are new supraglottic airway devices for children. The i-gel is made of a soft, gel-like elastomer with a noninflatable cuff. The air-Q is a new single-use device that may optimise the airway seal while reducing the potential for postoperative complications such as sore throat. The overall structure of the air-Q SP is identical to the original air-Q, except with regard to the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the i-gel and the air-Q SP.

Who can participate

Age range

1 Month – 108 Months

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: * Children (1-108 month of age and 7-30kg) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway Exclusion Criteria: * Patients with a potentially difficult airway, risk of aspiration such as gastroesophageal reflux disease, or active upper respiratory tract infection

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

airway leak pressure

Timeframe: within 5 min after insertion of each device

Trial details

NCT IDNCT02140008

SponsorYonsei University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-05

View on ClinicalTrials.gov More General Anesthesia trials