Safety and Efficacy of the LMA Supreme Supraglottic Airway Device When Used for Adult Patients Undergoing Spinal Surgery in the Prone Position
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The efficacy of the LMA Supreme device as assessed by measurement of ventilation on Case Report Form 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The efficacy of the LMA Supreme device as assessed by measurement of ventilation on Case Report Form 1
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Intraoperative
Outcome being measured intraoperatively is did patient develop any intraoperative episodes of laryngospasm, hiccups, or coughing.
次要结局
- Dysphagia Short Questionnaire(Preoperative and up to 4 weeks postoperative (+/- 5 days).)