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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Placement of the LMA Supreme supraglottic airway device for patients undergoing outpatient spine surgery in the prone position.
Laser Spine Institute
Tampa, Florida, United States
RECRUITINGThe efficacy of the LMA Supreme device as assessed by measurement of ventilation on Case Report Form 1
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
Time frame: Intraoperative
The efficacy of the LMA Supreme device as assessed by measurement of ease of swallowing on Case Report Form 2
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).
Time frame: Preoperative and up to 4 weeks (+/- 5 days) postoperative
The efficacy of the LMA Supreme device as assessed by measurement of removal of the LMA Supreme Device on Case Report Form 1
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.
Time frame: Intraoperative
The efficacy of the LMA Supreme device as assessed by measurement of any intraoperative episodes developing reporting outcomes on Case Report Form 1
Outcome being measured intraoperatively is did patient develop any intraoperative episodes of laryngospasm, hiccups, or coughing.
Time frame: Intraoperative
Dysphagia Short Questionnaire
Instrument used to measure difficulty swallowing (dysphagia).
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Time frame: Preoperative and up to 4 weeks postoperative (+/- 5 days).