Effect of Different Water Injection Temperatures on the Safety and Comfort of Patients Undergoing Ultrasound Endoscopy of Small Probes Under Intravenous Anesthesia

Central South University

Status

Completed

Conditions

The Water Temperature

Small Probe Ultrasound Endoscopy

Treatments

Other: Change the water injection temperature

Study type

Observational

Funder types

Other

Identifiers

NCT05454475

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Details and patient eligibility

About

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.

Enrollment

270 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Age ≥ 18 years old;
Gastrointestinal (GI) mucosal or submucosal lesions detected by general endoscopy;
Require small-probe ultrasonic endoscopy (mEUS) under sedation for definitive diagnosis;
Clearly understand the study and voluntarily participate, with informed consent provided.

Exclusion Criteria

Failure to meet the requirements for mEUS examination and anaesthesia, or need to use multiple sedative and analgesic drugs;
Pregnancy or breastfeeding;
Chronic use of opioids and benzodiazepines;
Structural changes in the GI tract caused by abdominal surgery;
Presence of mental illness;
Presence of lesions in the oesophagus.