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UNKNOWNNCT03633942

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

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 de...

Lead sponsor: Laser Spine Institute•1 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Catrina Montgomery

CONTACT

813-392-7435 [email protected]

Sean Perry

CONTACT

[email protected]

Sponsors

Lead Sponsor

Laser Spine Institute

Collaborators

Teleflex

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. During surgery, standard treatment will be applied, complemented with the recording of study parameters related to safety, efficacy and performance of the LMA Supreme laryngeal mask airway.

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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
•Inability to comply with study requirements including follow-up

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 24, 2018Terms

Trial snapshot

StatusUNKNOWN

Phase—

Enrollment1,000

Start dateJul 2018

Last updatedAug 24, 2018

Condition

Airway Obstruction

Locations shown

Laser Spine Institute

Tampa, Florida

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 24, 2018Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions