UnknownNot Applicable

Safety and Efficacy of the LMA Supreme When Inserted With Patients in the Prone Position

United States1,000 participantsStarted 2018-07-27

Plain-language summary

This study is a non-randomized, observational, non-comparative prospective study to evaluate the safety, efficacy and performance of the LMA Supreme laryngeal mask airway when used according to the device's Instructions for Use.

Who can participate

Age range

18 Years – 70 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: * 18 to 70 years of age * American Society of Anesthesiology Classification (ASA) I-III patients * Fasting for 8 hours * Scheduled surgery with indication for laryngeal mask airway Exclusion Criteria: * Have contraindicating conditions * Have had radiotherapy to the neck involving the hypopharynx (risk of trauma, failure to seal effectively). * Have inadequate mouth opening to permit insertion * History of hiatal hernia * Scheduled for minimally invasive spine stabilization procedures such as Transforaminal Lumbar Interbody Fusion (TLIF), Anterior Cervical Discectomy and Fusion (ACDF) (all have neuromonitoring/general endotracheal intubation) * Scheduled for Joimax procedure (initial anesthetic is MAC) * Unable to safely position themselves prone with assistance * History of previous failed LMA Supreme placement * BMI greater than or equal to 53 * Outside age or ASA range specified in inclusion criteria * Inability to comply with study requirements including follow-up

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

The efficacy of the LMA Supreme device as assessed by measurement of ventilation on Case Report Form 1

Timeframe: Intraoperative

The efficacy of the LMA Supreme device as assessed by measurement of ease of swallowing on Case Report Form 2

Timeframe: Preoperative and up to 4 weeks (+/- 5 days) postoperative

The efficacy of the LMA Supreme device as assessed by measurement of removal of the LMA Supreme Device on Case Report Form 1

Timeframe: Intraoperative

The efficacy of the LMA Supreme device as assessed by measurement of any intraoperative episodes developing reporting outcomes on Case Report Form 1

Timeframe: Intraoperative

Trial details

NCT IDNCT03633942

SponsorLaser Spine Institute

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-07-27

Contact for this trial

Catrina Montgomery

813-392-7435 cmontgomery@laserspineinstitute.com

View on ClinicalTrials.gov More Airway Obstruction trials

Who can participate

Age range

18 Years – 70 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.

What they're measuring

The efficacy of the LMA Supreme device as assessed by measurement of ventilation on Case Report Form 1

Timeframe: Intraoperative

The efficacy of the LMA Supreme device as assessed by measurement of ease of swallowing on Case Report Form 2

Timeframe: Preoperative and up to 4 weeks (+/- 5 days) postoperative

The efficacy of the LMA Supreme device as assessed by measurement of removal of the LMA Supreme Device on Case Report Form 1

Timeframe: Intraoperative

The efficacy of the LMA Supreme device as assessed by measurement of any intraoperative episodes developing reporting outcomes on Case Report Form 1

Timeframe: Intraoperative