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

Laser Spine Institute

Status: Unknown

Conditions: Airway Obstruction

Treatments: Device: LMA Supreme

Study type: Observational

Funder types: Industry

Identifiers

NCT03633942

LMA 200

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

Observational: LMA Supreme

Description:

An appropriately sized LMA Supreme will be prepared by removing all air from the cuff while applying manual pressure. A water soluble non-local anesthetic containing lubricant gel will be applied to the fully deflated airway before insertion. A 1 cm column of the gel will be preloaded into the gastric port of the LMA Supreme for the Gel Test. The cuff will be inflated with a manometer to a pressure of approximately 30cm H2O. If a significant leak is detected, the cuff will be inflated in increments of 5cm H2O until a satisfactory seal is obtained. The final cuff pressure will be recorded. The lungs will then be gently inflated by applying manual pressure to the anesthesia circuit bag while observing the gel column in the LMA Supreme gastric port for movement.

Treatment:

Device: LMA Supreme