Multi-center Pivotal Clinical Trial to Compare the Safety and Effectiveness of Procedural Sedation in GI Endoscopy: A Computer-Assisted Personalized Sedation (CAPS) Device Versus Current Standard of Care
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 14
- 主要终点
- Area Under the Curve for Oxygen Desaturation (AUCDesat)
研究概览
简要总结
Patients routinely receive sedation during a colonoscopy or upper endoscopy (esophagogastroduodenoscopy; EGD) procedure. Propofol is a sedative that can be used during these procedures. The purpose of this study is to determine if this CAPS device enables a physician/registered nurse (RN) team to safely and effectively administer propofol sedation during colonoscopy or EGD procedures relative to current sedation practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old
- •Able to comprehend, sign, and date the written informed consent form
- •English as primary language
- •Undergoing a non-emergent EGD or colonoscopy
- •Have taken nothing by mouth for a minimum of 6 hours prior to the study procedure
- •American Society of Anesthesiologists (ASA) Class I, II or III
排除标准
- •Allergy or inability to tolerate study medications or components of study medications
- •Investigator anticipates greater than 45 minute procedure time due to known anatomical difficulty
- •Currently using a fentanyl patch
- •History of diagnosed sleep apnea
- •History of diagnosed gastroparesis
- •Baseline oxygen saturation < 90% (room air)
- •Pregnant or nursing females
- •Body mass index (BMI) ≥ 35
- •Participation in a clinical trial within the past 30 days.
结局指标
主要结局
Area Under the Curve for Oxygen Desaturation (AUCDesat)
时间窗: From administration of initial drug dose until subject recovered from effects of sedation
AUCDesat measures desaturation as a function of incidence, magnitude, and duration. AUCDesat is the difference between the threshold and actual oxygen saturation measured every second. The total area below the 90% threshold is summated to determine AUCDesat in units of seconds\*percent.
次要结局
- Duration of Deep Sedation/General Anesthesia(From first dose until subject recovered from effects of sedation)
- Patient Satisfaction(24-48 hours post sedation)
- Clinician Satisfaction(Post procedure)
- Recovery Time (From Sedation)(from "scope out" until first of two consecutive MOAA/S scores of 5)