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

Small probe endoscopy is currently the best way to diagnose submucosal lesions of the digestive tract. Ultrasonic endoscopy of small probes requires filling the probe and the air in the lumen with water to eliminate gas. Water injection may cause patients with nausea and vomiting, choking cough, abdominal pain, bloating and other uncomfortable symptoms, and in severe cases, it may cause adverse consequences such as breath holding, arrhythmia, and increased blood pressure. At present, some studies have improved patient discomfort by changing the water injection method and developing new acoustic media during the ultrasonic endoscopy of small probes. At present, there are no studies on the impact of different water injection temperatures on the safety and comfort of patients undergoing small probe ultrasound endoscopy under intravenous anesthesia.

In order to improve patient comfort and cooperation, the vast majority of patients currently undergo ultrasound endoscopy under intravenous anesthesia. Under the action of anesthesia and sedative drugs, the patient's thermoregulation center is inhibited, and the change of external temperature is often more obvious to the patient's hemodynamics. Previous studies have found that the temperature of ingested water has an effect on human hemodynamics, digestive tract peristalsis, and visceral body temperature receptors. Injection of relatively low temperature water may reduce the patient's cardiopulmonary load, delay gastrointestinal motility, and shorten the duration of examination; Injecting room or center temperature water may reduce patient coldness and improve patient comfort. Therefore, it is interesting to explore the effects of different water injection temperatures on the safety and comfort of patients with small probe ultrasound endoscopy under intravenous anesthesia, and aim to identify an optimal water injection temperature that can ensure the safety of patient examination and improve patient comfort.

Study Overview

• Status: Recruiting
• Conditions: Small Probe Ultrasound Endoscopy; The Water Temperature
• Intervention / Treatment: Other: Change the water injection temperature

• Study Type: Observational
• Enrollment (Anticipated): 372

Contacts and Locations

• Study Contact: Name: L Tian; Phone Number: 0731-13574843423; Email: f3tianli@outlook.com
• Study Contact Backup: Name: X Yu; Phone Number: 0731-15874866288; Email: yuxiaoyu232@163.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • he Third Xiangya Hospital of Central South University
      • Contact: Li Tian, MD; Phone Number: 13574843423; Email: fieldpower927@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• Age ≥ 18 years old, ≤ 75 years old;
• Gastrointestinal tract raised lesions can be seen in gastrointestinal microscopy;
• Ultrasonic endoscopy of small probes under intravenous anesthesia is proposed;
• Clearly understand and voluntarily participate in the study, and sign an informed consent form.

Exclusion Criteria:

• Exclude patients who do not meet the requirements of conventional small probe ultrasound endoscopy and sedation due to their own conditions: for example, arrhythmias, heart failure, acute myocardial infarction, bronchial asthma during attacks, cervical and thoracic spinal deformities, delirium, mental disorders, duodenal perforations with acute inflammation, etc.;
• Exclude patients with long-term use of opioids and benzodiazepines;
• Elimination of pregnant and breastfeeding patients.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Low temperature group; The temperature is 6℃-10℃.	Other: 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℃.	Other: 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℃.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of cardiopulmonary adverse events	Respiratory depression, apnea, hypotension, hypertension, tachycardia, bradycardia, etc.	The examination begins until 24 hours after the examination
Patient comfort	Likert scale The lowest score is 1, and the highest score is 5. A score of 1 is very uncomfortable, and a score of 5 is very uncomfortable. The higher the score, the more comfortable the patient.	The examination begins until 24 hours after the examination

Collaborators and Investigators

• Sponsor: The Third Xiangya Hospital of Central South University
• Investigators: Study Chair: L Tian, The Third Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: June 12, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 8, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: fu3tianli

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No