Small Probe Ultrasound EndoscopyNCT05454475
Effect of Different Water Injection Temperatures on the Safety and Comfort of Patients Undergoing Ultrasound Endoscopy of Small Probes Under Intravenous Anesthesia
An observational study of Small Probe Ultrasound Endoscopy and The Water Temperature, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Probe Ultrasound Endoscopy, The Water Temperature
- What is being tested?
- Change the water injection temperature
- Type of treatment
- Injection or infusion
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
he Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
About this study
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.
- Being tested
- Change the water injection temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change the water injection temperatureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Low temperature group | The temperature is 6℃-10℃. Receives: Other: Change the water injection temperature | |
| room temperature group | The temperature is 20℃-24℃. Receives: Other: Change the water injection temperature | |
| Core temperature group | The temperature is 35℃-39℃. Receives: Other: Change the water injection temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 6 months after mEUS examination
Secondary outcomes (4)
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).
Measured: During mEUS examination
Haemodynamic indices
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).
Measured: 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.
Measured: 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).
Measured: Post-anesthesia recovery (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start14 Jun 2022
- Primary completion1 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Probe Ultrasound EndoscopyStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Tian, MD, The Third Xiangya Hospital of Central South University
- Investigators
- L Tian, Study chair, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454475
- Sponsor's protocol ID
- fu3tianli
- Status last verified
- Jul 2022
- First submitted
- 12 Jun 2022
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Water Injection Temperatures on the Safety and Comfort of Patients Undergoing Ultrasound Endoscopy of Small Probes Under Intravenous Anesthesia
- ClinicalTrials.gov ID
- NCT05454475
- Acronym / sponsor ID
- fu3tianli
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low temperature group | – | Other: Change the water injection temperatureThe temperature is 6℃-10℃. |
| room temperature group | – | Other: Change the water injection temperatureThe temperature is 20℃-24℃. |
| Core temperature group | – | Other: Change the water injection temperatureThe temperature is 35℃-39℃. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change the water injection temperatureWater 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. | Other | Core temperature group, Low temperature group, room temperature group |
Primary outcome
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.
4 secondary outcomes
Gastrointestinal (GI) peristaltic grade
Time frame: During mEUS examination
Haemodynamic indices
Time frame: At T0, T1, T2, T3, T4, and T5 time points
Adverse events
Time frame: Periprocedural (from anesthesia assessment to post-anesthesia wakefulness)
Somatic and psychological feeling scores
Time frame: Post-anesthesia recovery (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
L Tian study chair
The Third Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Probe Ultrasound Endoscopy and The Water Temperature, run by The Third Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mEUS image quality (time frame: From examination initiation through 24 hours post-examination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.