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



Status:Recruiting
Healthy:No
Age Range:18 - 70
Updated:8/26/2018
Start Date:July 27, 2018
End Date:July 27, 2020
Contact:Catrina Montgomery
Email:cmontgomery@laserspineinstitute.com
Phone:813-392-7435

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Safety and Efficacy of the LMA Supreme Supraglottic Airway Device When Used for Adult Patients Undergoing Spinal Surgery 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 device's Instructions for Use.

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.

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
We found this trial at
1
site
Tampa, Florida 33607
Principal Investigator: Thor Van Diver, MD
Phone: 813-392-7435
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mi
from
Tampa, FL
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