Airway Obstruction
Conditions
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.
Interventions
DEVICELMA Supreme
Placement of the LMA Supreme supraglottic airway device for patients undergoing outpatient spine surgery in the prone position.
Sponsors
Teleflex
Laser Spine Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Dysphagia Short Questionnaire | Preoperative and up to 4 weeks postoperative (+/- 5 days). | Instrument used to measure difficulty swallowing (dysphagia). |
Countries
United States
Contacts
Primary ContactCatrina Montgomery
Backup ContactSean Perry
Outcome results
None listed