Effect of Different Water Injection Temperatures on the Safety and Comfort of Patients Undergoing Ultrasound Endoscopy of Small Probes Under Intravenous Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- mEUS image quality
研究概览
简要总结
Miniprobe endoscopic ultrasonography (mEUS) is a key diagnostic modality for gastrointestinal (GI) mucosal or submucosal lesions, requiring water infusion to eliminate intraluminal air and improve image clarity. However, the optimal water temperature for sedated mEUS remains uncertain-previous studies suggest water temperature may affect GI peristalsis, haemodynamics, image quality, and patient safety/comfort, but no research has focused on this topic in sedated mEUS.
This is a prospective, multicentre, double-blind, randomized controlled study. Eligible patients (≥18 years with GI mucosal/submucosal lesions requiring sedated mEUS) are randomly assigned to three groups based on water temperature: cold water (6-10 °C), warm water (20-24 °C), and hot water (35-39 °C). The primary objectives are to evaluate the effects of different water temperatures on mEUS image quality (standardized scoring) and diagnostic accuracy. Secondary outcomes include GI peristaltic grade, haemodynamic indices (measured at 6 time points), adverse events, and patient somatic/psychological feeling, comfort, and satisfaction scores.
The study aims to identify the optimal water temperature that reduces GI peristalsis, improves mEUS diagnostic performance, and ensures patient safety and comfort during sedated mEUS, providing evidence for standardized clinical practice.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
mEUS image quality
时间窗: From examination initiation through 24 hours post-examination
Assessed by two independent experts (excluding the operating endoscopist) using Soon's scoring method on a 1-5 scale: 1 = air artifact obscures target lesion; 2 = air artifact severely impairs lesion size/characteristic assessment; 3 = air artifact mildly impairs lesion size/characteristic assessment; 4 = air artifact present but does not compromise lesion assessment; 5 = no air artifact with unimpaired lesion assessment. Scores 1-2 = poor, 3-4 = good, 5 = excellent.
mEUS diagnostic accuracy
时间窗: Up to 6 months after mEUS examination
Gold standard confirmation: surgical, ESD or puncture histopathological results for patients with tissue specimens; ≥6-month clinical follow-up (based on manifestations, test results, lesion size and echogenic changes) for determining benign/malignant nature in other patients.
次要结局
- Somatic and psychological feeling scores(Post-anesthesia recovery (Day 1))
- Gastrointestinal (GI) peristaltic grade(During mEUS examination)
- Adverse events(Periprocedural (from anesthesia assessment to post-anesthesia wakefulness))
- Haemodynamic indices(At T0, T1, T2, T3, T4, and T5 time points)
研究者
Li Tian, MD
associate professor
The Third Xiangya Hospital of Central South University