Comparison of Techniques to Improve Oxygenation and Capnographic Detection During Sedative Gastrointestinal Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Area under the curve of 95% oxygen desaturation (AUCdesat)
研究概览
简要总结
The purpose of this study is to compare the effect of mandibular advancement bite block and high flow nasal cannula to standard bite block for oxygenation, capnographic measurement, prevention of hypoxemia, intervention events and adverse effects during endoscopic examinations.
详细描述
During endoscopic examinations, especially during those performed via oral insertion of endoscopes, an oral bite is used to protect the examination instruments and patients. During sedated endoscopic examinations, the patients are under influence of anesthetics. Upper airway obstruction often occurred due to respiratory depression and airway collapse resulting in desaturation. Airway management with high percentage oxygen, jaw thrust, or insertion of nasal airways by trained anesthetic personnel is required during upper airway obstruction emergencies. Nasal airway is invasive and causes nasal bleeding, sinusitis and other problems. Jaw thrust and bag-mask ventilation requires training and is a burden to anesthetic personnel to perform. Oxygenation and capnography are important ventilatory monitors during sedative procedures. These are often influenced by open mouth breathing during upper gastrointestinal endoscopic examinations making oxygenation and capnographic measurements unreliable. In this study, we group the patients into A group using standard of care, B group using mandibular advancement oral bite and C group using high-flow nasal cannulas. After anesthetic induction, gastric endoscopy will be performed. Oxygenation, end-tidal carbon dioxide, and degree of upper airway obstruction will be evaluated and recorded. Differences between the groups will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Male and female patients aged 20 to 80 years with ASA physical status I to II undergoing routine outpatient upper gastrointestinal endoscopy
排除标准
- •Baseline oxygen saturation < 90%
- •Known upper airway obstruction, difficult intubation history
- •Unstable or lost of upper and lower incisors
- •Known past oral or neck surgeries
- •Anticipate exam time > 30 mins
结局指标
主要结局
Area under the curve of 95% oxygen desaturation (AUCdesat)
时间窗: From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
AUCdesat is defined as the integrated area under oxygen saturation (SPO2) for a selected cut point per 30 seconds, which better reflects the duration and severity of hypoxemia than the lowest saturation
次要结局
- Number of total airway obstruction episodes(From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour)
- Number of apnea episodes(From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour)
- Number of partial airway obstruction episodes(From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour)
- Number of rescue interventions(From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour)