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.
Study Type
OBSERVATIONAL
Enrollment
270
Water injection is a routine procedure for endoscopy of small probe ultrasound, and our intervention is to change the water temperature and observe the effects of different water temperatures on patient safety and comfort.
he Third Xiangya Hospital of Central South University
Changsha, Hunan, China
mEUS image quality
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.
Time frame: From examination initiation through 24 hours post-examination
mEUS diagnostic accuracy
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.
Time frame: Up to 6 months after mEUS examination
Gastrointestinal (GI) peristaltic grade
Assessed by two independent experts (excluding the operating endoscopist) via recorded video, using Hiki's upper GI peristaltic score and Likman Mui's lower GI peristaltic score (1=no peristalsis; 5=markedly vigorous peristalsis).
Time frame: During mEUS examination
Haemodynamic indices
Includes mean arterial pressure (MAP), heart rate (HR), and oxygen saturation (SpO2); measured at 6 time points: anaesthesia assessment (T0), endoscopy (T1), before water infusion (T2), at water infusion (T3), after total water aspiration (T4), and at wakefulness (T5).
Time frame: At T0, T1, T2, T3, T4, and T5 time points
Adverse events
Includes coughing, choking, aspiration, hypotension (MAP during/after water infusion \<20% of pre-infusion level), bradycardia (HR \<50 beats/min), tachycardia (HR \>100 beats/min), hypoxaemia (SpO2 \<90%), bleeding, perforation, and infection.
Time frame: Periprocedural (from anesthesia assessment to post-anesthesia wakefulness)
Somatic and psychological feeling scores
Assessed via questionnaire post-anesthesia recovery: somatic discomfort (nausea/vomiting, bloating, coldness, anxiety); pain (VAS: 0=no pain to 10=severe pain); comfort and satisfaction (5-point Likert scale: 1=very uncomfortable/dissatisfied to 5=very comfortable/satisfied).
Time frame: Post-anesthesia recovery (Day 1)
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