The Effect of A Novel End-Tidal Carbon Dioxide Monitoring Device for Sedation During Endoscopic Ultrasonography-Guided Fine Needle Aspiration
试验速览
- 阶段
- 不适用
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Peripheral oxygen saturation
研究概览
简要总结
To meet the needs of both operators and patients, moderate and deep sedation has been widely used in digestive endoscopy, which is invasive and painful. With its pleasant effects, sedation has complications nevertheless. And respiratory depression is the most common one, which makes respiratory monitoring significant. SpO2 and respiratory motion are regularly monitored without satisfying timeliness or sensitivity. Capnography with current device is only able to detect either oral or nasal breathing. The present study was designed to test the effect of the investigator's modified End-Tidal Carbon Dioxide (ETCO2) monitoring device for sedation during endoscopic ultrasonography-guided fine needle aspiration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for ultrasonography-guided fine needle aspiration
- •Adult patients aged 18 to 65 years
- •American Society of Anesthesiologists (ASA) Physical Status Classification I-III
- •Subjects provide informed consent
排除标准
- •Full stomach or upper gastrointestinal tract obstruction
- •Baseline pulse oximetric saturation (SpO2) <95% while breathing room air
- •Obesity （BMI≥28kg/m2）or anticipated difficult airway
- •Cardiovascular or cerebrovascular events within 3 months
- •Pregnancy
- •Chronic opioid user
- •Allergic to anesthetics
结局指标
主要结局
Peripheral oxygen saturation
时间窗: Across the sedation, assessed up to 2 hours
Peripheral oxygen saturation is measured by pulse oximetry and hypoxemia is defined as SpO2≤91%
次要结局
- Arterial pO2 and pCO2(30 minutes after initiation of the sedation)
- Incidence of hypertension and hypotension(From the completion of sedation to the completion of endosonography procedure, assessed up to 2 hours)
- Total dosage of propofol(Across the sedation, assessed up to 2 hours)
- The numbers of the times of body movement(From the completion of sedation to the completion of endosonography procedure, assessed up to 2 hours)
- Recovery time(After termination of the sedation medication, assessed up to 2 hours)
- Satisfaction score of the patients and endosonographers(Across the procedure, assessed up to 2 hours)
研究者
Jia-feng Wang
Principal Investigator
Changhai Hospital