Mandibular Advancement Bite Block Efficacy Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Area under curve of 95% oxygen desaturation
研究概览
简要总结
The purpose of this study is to compare the effect of mandibular advancement bite block to standard bite block for prevention of hypoxemia, intervention events and adverse effects during endoscopic examinations.
详细描述
During endoscopic examinations, especially upper gastrointestinal, bile duct, or bronchoscopic examinations, the endoscope need to be placed through the mouth. A bite block is used to protect vulnerable endoscope and protect patient's teeth. During sedative endoscopic exams, respiratory depression, apnea or upper airway obstruction will occur under the influence of the sedative medications. Serious adverse events may occur such as hypoxemia. A nasal airway, Larson's maneuver, jaw thrust or chin lift may be needed to open airways.
Mandibular advancement devices has been widely used in treating obstructive sleep apnea. A modified bite block that provides mandibular advancement could provide entry inlet of endoscope as well as provide mandibular advancement to provide patent airway during sedative endoscopy. In this study, we group the patients into test group using mandibular advancement bite block and a control group using standard bite block. After anesthetic induction, gastric endoscopy was performed. Degree of upper airway obstruction will be evaluated and recorded. Differences between the two groups will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologist class I or II
- •Patients undergoing routine upper gastrointestinal endoscopy under sedation
排除标准
- •Baseline oxygen saturation < 90%
- •Known difficult airway
- •Oral or facial surgery history
- •BMI > 35
- •patients with gastroparesis or gastrointestinal bleeding
- •anticipated exam time > 30 minutes
结局指标
主要结局
Area under curve of 95% oxygen desaturation
时间窗: up to 30 minutes
From start of sedation drug administration to end of endoscopic examination with the endoscope withdrawal from patient's mouth, peripheral oxygen saturation recorded. Area under curve of 95% oxygen desaturation is calculated by (95-saturation) x time.
次要结局
- Adverse events: partial or complete airway obstruction, or apnea(up to 30 minutes)
- number of rescue interventions: chin lift, jaw thrust, insertion of nasal airway or mask-bag ventilation(up to 30 minutes)