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

• Conditions: Airway Obstruction

• Registration Number: NCT03633942
• Lead Sponsor: Laser Spine Institute

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-06-29
• Study Start: 2018-07-27
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-16
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-24
• Primary Completion: 2019-07-27
• Study Completion: 2020-07-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The efficacy of the LMA Supreme device as assessed by measurement of ventilation on Case Report Form 1	Intraoperative	Outcome being measured intraoperatively is the ease of manual ventilation via the LMA Supreme. Measuring, no air leaks, air leak / elevated airway pressure needed for adequate ventilation, removal and reinsertion needed to achieve adequate ventilation, no ventilation after 2 attempts (airway managed using alternative techniques
The efficacy of the LMA Supreme device as assessed by measurement of ease of swallowing on Case Report Form 2	Preoperative and up to 4 weeks (+/- 5 days) postoperative	Outcome being measured preoperatively and at 4 weeks +/- 5 days is the Dysphagia (difficulty swallowing) Short Questionnaire. Measuring the ability to swallow (any difficulty in swallowing), incorrect swallowing (any coughing associated with swallowing), lump feeling (any lumps in the throat), involuntary loss of weight (any weight loss recently), Pneumonia (any bouts with pneumonia).
The efficacy of the LMA Supreme device as assessed by measurement of removal of the LMA Supreme Device on Case Report Form 1	Intraoperative	Outcome being measured intraoperatively is any blood on the LMA upon removal. Measuring if there is minimal or no blood, blood covering less than one fourth of the LMA or blood on at least one half of the LMA surface.
The efficacy of the LMA Supreme device as assessed by measurement of any intraoperative episodes developing reporting outcomes on Case Report Form 1	Intraoperative	Outcome being measured intraoperatively is did patient develop any intraoperative episodes of laryngospasm, hiccups, or coughing.

Secondary Outcome Measures

Name	Time	Method
Dysphagia Short Questionnaire	Preoperative and up to 4 weeks postoperative (+/- 5 days).	Instrument used to measure difficulty swallowing (dysphagia).

Trial Locations

Locations (1)

Laser Spine Institute; 🇺🇸 Tampa, Florida, United States