Performance Characteristics and Technical Outcomes of Single-use Gastroscopes Used Bedside Versus Reusable Gastroscopes Used in the Endoscopy Unit Evaluated in Subacute Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Time from the indication/decision for early endoscopy to procedure
研究概览
简要总结
The aim of this study is to investigate whether single-use gastroscopes used bedside can reduce the time from indication to procedure compared with re-usable gastroscopes used at the endoscopy unit in patients referred to a subacute gastroscopy.
Participants in the first period will be scheduled for gastroscopy with a re-usable gastroscope in the endoscopy unit, whereas participants during the second period will have a gastroscopy performed at the ward (bed-side) with a single-use gastroscope.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients of any gender, 18 years of age or older admitted to the acute section of the surgical department (Kir2) at Zealand University Hospital referred to early EGD without general anesthesia.
排除标准
- •ASA-score of 4 or higher
- •Unstable patient
- •Suspicion of ventricular retention
- •Suspicion of active bleeders
- •Need for expert endoscopist to perform the procedure, e.g. stenting
- •Patients < 18 years of age
研究组 & 干预措施
Reusable gastroscope in the endoscopy unit
In the first period the subacute gastroscopies will be performed with a reusable gastroscope in the endoscopy unit.
干预措施: Diagnostic gastroscopes, Olympus (Device)
Single-use gastroscope bedside in the patient's room
In the second period the subacute gastroscopies will be performed with a reusable gastroscope in bedside in the patients' rooms.
干预措施: Ambu aScope Gastro (Device)
结局指标
主要结局
Time from the indication/decision for early endoscopy to procedure
时间窗: From indication to procedure, up to two weeks
次要结局
- Duration of the procedure(During the procedure)
- Time from indication to the discharge(From indication to discharge, up to 3 months)
- Time from procedure to discharge(From procedure to discharge, up to 3 months)
- Did the patient need sedation or local anesthetic throat spray(During the procedure)
- Technical success(From admission to discharge, up to 3 months)
- Sufficient ability to target the biopsy if taken(During the procedure)
- Complications to gastroscopy(24 and 72 hour follow-up after procedure)
- 30th day mortality(30 days)
- Readmission(30 days after procedure)
- The necessity for a new gastroscopy, including the reasons justifying it(During admission, up to 3 months)
- Endoscopists' rating of the gastroscope(Right after procedure)
- Learning curve for nurses at the surgical department(During the second period (one year))
研究者
Camilla Kjelkvist-Born
Principal Investigator
Zealand University Hospital