Completed

NCT Number: NCT05454475

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

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.

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Key information

Conditions

Small Probe Ultrasound Endoscopy The Water Temperature

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

he Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

mEUS image quality

Time frame: 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

Time frame: 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.

Secondary outcomes

Gastrointestinal (GI) peristaltic grade

Time frame: During mEUS examination

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).
Haemodynamic indices

Time frame: At T0, T1, T2, T3, T4, and T5 time points

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).
Adverse events

Time frame: Periprocedural (from anesthesia assessment to post-anesthesia wakefulness)

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.
Somatic and psychological feeling scores

Time frame: Post-anesthesia recovery (Day 1)

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).

Sponsors and collaborators

Lead sponsor

The Third Xiangya Hospital of Central South University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jul 12, 2022
Registry last updated: Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.