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

NCT05454475 | Completed

• 1 other identifier: fu3tianli
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Small Probe Ultrasound Endoscopy; The Water Temperature

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Gastrointestinal (GI) peristaltic grade

  During mEUS examination

• Haemodynamic indices

  At T0, T1, T2, T3, T4, and T5 time points

• Adverse events

  Periprocedural (from anesthesia assessment to post-anesthesia wakefulness)

• Somatic and psychological feeling scores

  Post-anesthesia recovery (Day 1)

Study Arms (3)

Low temperature group

The temperature is 6℃-10℃.

Other: Change the water injection temperature

room temperature group

The temperature is 20℃-24℃.

Other: Change the water injection temperature

Core temperature group

The temperature is 35℃-39℃.

Other: Change the water injection temperature

Interventions

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.

Core temperature group; Low temperature group; room temperature group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

he Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Study Officials

• L Tian

  The Third Xiangya Hospital of Central South University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: June 12, 2022
• First Posted: July 12, 2022
• Study Start: June 14, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 30, 2023
• Last Updated: December 26, 2025

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)