Sedation for Endoscopic Procedures - a Follow-up Study of Efficiency and Safety
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Dimensions of recovery recorded by Quality of Recovery 15 swedish version
研究概览
简要总结
Endoscopic procedures for biliary strictures, stenting or drainage (ERCP) and ultrasonic imaging or biopsies (EUS) are performed under sedation or anesthesia. The main purpose of the study is to evaluate aspects of procedure treatability and patients´ quality of recovery.
详细描述
The main aim of this study is to evaluate the effects on treatability and procedure failur; also aspects of post-procedure quality of recovery from patients cognitive function and from the choice of sedation/anesthesia for ERCP and EUS-procedures.
Before endoscopic procedures, patients do not always read the written information sent to them. That´s a problem since patients tend to be insufficient prepared for the procedures. Therefore, evaluation of patients' health literacy was performed.
Patients are sedated (patient-controlled sedation or by nurse anesthetists) or in general anesthesia. No randomisation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients (≥18 years)
- •Patients cheduled for ERCP or/and EUS
- •Patients who have given their informed and written concent to participate
排除标准
- •Patients with
- •confusion
- •communication problems.
结局指标
主要结局
Dimensions of recovery recorded by Quality of Recovery 15 swedish version
时间窗: Day 5
Quality of recovery (QoR15 swedish version) Max 150 points Min 0, higher scores are better
次要结局
- Health literacy measured by the use of FHL (swedish version)(Before procedure (Day 0))
- Aborted or increased difficulty to performed the planned procedure(From start of procedure to the end of it (Day 0))
研究者
Andreas Nilsson
Senior nurse anesthetist, Researcher, Principal Investigator
Ostergotland County Council, Sweden