NCT04502485Unknown不适用
Reduce Patient Discomfort With Water Exchange Method During Upper Endoscopy
Yu-Hsi hsieh2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2019年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Discomfort during the procedure
研究概览
简要总结
The aim of the study was to evaluate the application of water exchange method to upper endoscopy. We hypothesize that water exchange during upper endoscopy could reduce patient discomfort. The primary outcome will be the patient discomfort score during upper endoscopy. The secondary outcomes will include cleanliness score, techniques adequacy score, findings of the EGD, and willing to repeat the procedure, as well as the patient and endoscopist satisfaction score with the method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients will include those anticipated to undergo EGD , aged 20 to 65 at the time of enrollment
排除标准
- •a therapeutic EGD
- •sedation with other agents
- •American Society of Anesthesiology (ASA) risk Class 3 or higher, renal failure
- •age less than 20 years or more than 65 years
- •pregnancy
- •refusal to provide written informed consent. All participants signed written informed consents
结局指标
主要结局
Discomfort during the procedure
时间窗: 5 minutes after the procedure
A VAS discomfort score (0, no discomfort; 10, most discomfort) graded by the patient,
次要结局
- mucosa cleanliness score(1 minutes after the procedure)
- patient satisfaction score(5 minutes after the procedure)
- technique adequacy score(1 minutes after the procedure)
研究者
Yu-Hsi hsieh
Dr.
Dalin Tzu Chi General Hospital
研究点 (2)
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