Clinical trial NCT05454475: Effect of Different Water Injection Temperatures on the Safety and Comfort of Patients Undergoing Ultrasound Endoscopy of Small Probes Under Intravenous Anesthesia
Official title: Effect of Different Water Injection Temperatures on the Safety and Comfort of Patients Undergoing Ultrasound Endoscopy of Small Probes Under Intravenous Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Small Probe Ultrasound Endoscopy
The Water Temperature
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of cardiopulmonary adverse events
timeFrame: The examination begins until 24 hours after the examination
measure: Patient comfort
timeFrame: The examination begins until 24 hours after the examination
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: he Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: The Third Xiangya Hospital of Central South University
name: L Tian
role: STUDY_CHAIR
References: