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

Status unconfirmed

Conditions studied: Airway Obstruction

In brief

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.

Key facts

Study ID

NCT03633942

Run by

Laser Spine Institute

People needed

1000

Starts

2018-07-27

Expected to finish

2020-07-27

Last updated by the study team

2018-08-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Laser Spine Institute — Tampa, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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