The Accuracy of the Performance and Placement Test for Predicting Supraglottic Airway Device (SAD) Position in the Hypopharynx as Confirmed With Video Laryngoscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- To evaluate the accuracy of the performance and placement tests for predicting SAD position in the hypopharynx as confirmed with video laryngoscopy
研究概览
简要总结
The supraglottic airway device (SAD) is currently widely used in patients undergoing general anaesthesia as a method of securing the airway. The usage of SAD does not require the patient to be paralysed prior to insertion, as opposed to an endotracheal tube.
Five tests have been recommend to ensure that the SAD can be used for advanced procedure after a blind insertion. These tests however are not confirmed with visual validation and hence the confirmation of optimal position can be misleading.
This study is conducted to validate by video laryngoscopy the five recommended tests for confirming the placement and efficacy of a SAD, thus enabling its safe application in institutions with limited availability of video laryngoscopes.
Subjects for this study will consist of patients scheduled for procedures under general anaesthesia in the University of Malaya Medical Centre (UMMC) who are amenable to supraglottic airway management.
详细描述
The five tests are divided into placement and performance tests.
The placement tests are:-
- Suprasternal notch test: a gel plug is inserted in the proximal one centimetre of the gastric drain outlet. Gentle tapping of the suprasternal notch will cause the gel to pulsate. This confirms the location of the gastric outlet tip is behind the cricoid cartilage.
- Bubble test: when ventilating the SAD, the gel plug in the gastric drain outlet will not move. This confirms the location of the gastric outlet tip is behind the cricoid cartilage.
- Insertion of 14G gastric tube (Ryle's tube) into the gastric drain outlet. Ease of insertion grading:-
1 - Easy 2 - Difficult 3 - Impossible
Confirmation of correct gastric tube placement is through detection of injected air by auscultation of the epigastrium and/or aspiration of gastric contents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for procedures under general anaesthesia in the University of Malaya Medical Centre (UMMC) who are amenable to supraglottic airway management.
排除标准
- •American Society of Anesthesiologists (ASA) physical status class IV and above
- •morbid obesity (BMI > 40kg/m2)
- •high risk of regurgitation or aspiration (e.g. symptomatic gastro-oesophageal reflux, hiatus hernia)
- •respiratory tract pathology (e.g. preoperative sore throat)
结局指标
主要结局
To evaluate the accuracy of the performance and placement tests for predicting SAD position in the hypopharynx as confirmed with video laryngoscopy
时间窗: Intraoperative (from commencement of SAD insertion until confirmation of satisfactory SAD placement via video-laryngoscopy)
If all five placement and performance tests are successful, optimal (Grade 1) view of the SAD from video-laryngoscopy is expected.
次要结局
未报告次要终点
研究者
Dr Md Ariff bin Md Yusof
Medical Officer
University of Malaya