Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low temperature group | The temperature is 6℃-10℃. |
| |
| room temperature group | The temperature is 20℃-24℃. |
| |
| Core temperature group | The temperature is 35℃-39℃. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Change the water injection temperature | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to 6 months after mEUS examination |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | During mEUS examination |
| Haemodynamic indices |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
In the Third Xiangya Hospital of Central South University, the First Affiliated Hospital of South China University, the South China Hospital Affiliated to the University of South China, the Hunan Provincial People's Hospital, and the First People's Hospital of Changde City, patients with small probe ultrasound endoscopy under intravenous anesthesia due to gastrointestinal bulge lesions.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| L Tian | The Third Xiangya Hospital of Central South University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| he Third Xiangya Hospital of Central South University | Changsha | Hunan | 410013 | China |
There is not a plan to make IPD available.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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). |
| 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. | 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). | Post-anesthesia recovery (Day 1) |