Effect of Different Water Injection Temperatures on the Safety and Comfort of Patients Undergoing Ultrasound Endoscopy of Small Probes Under Intravenous Anesthesia
NCT ID: NCT05454475
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
270 participants
OBSERVATIONAL
2022-06-14
2023-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low temperature group
The temperature is 6℃-10℃.
Change the water injection temperature
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.
room temperature group
The temperature is 20℃-24℃.
Change the water injection temperature
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.
Core temperature group
The temperature is 35℃-39℃.
Change the water injection temperature
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Change the water injection temperature
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Third Xiangya Hospital of Central South University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Li Tian, MD
associate professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
L Tian
Role: STUDY_CHAIR
The Third Xiangya Hospital of Central South University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
he Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
fu3tianli
Identifier Type: -
Identifier Source: org_study_id