The Diagnosis and Treatment System of Transesophageal Echocardiography in ICU

Critically Ill Clinical Trial

Official title:

The Diagnosis and Treatment System of Transesophageal Echocardiography in ICU

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03811730
• Other study ID #: TEE
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: September 30, 2023

Study information

• Verified date: July 2021
• Source: West China Hospital
• Contact: Yi Li, PhD
• Phone: (+86)13438168612
• Email: 526563716[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Transesophageal ultrasound offers imaging through the esophagus on the surface of the heart, with good image quality and unique advantages. However, no studies to date have examined its effect in critically ill patients in China.Therefore, the investigators aimed to compare the efficacy and safety of TEE with TTE. the investigators will conducte a Multi-center, prospective observational control study enrolling critically ill adult patients in several ICU in China .

Description:

Patients in ICU were assessed for the need for TEE by trained researcher. Eligible patients would be conducted tee examination by researcher A, TTE by the researcher B ,at the same time, researcher C records the basic condition and clinical data of patientsand carried out micro-enlargement test.The examination results are judged by A and B respectively and provided to the physician of this patient, and A return visit to the physician wold be conducted by researcher D to evaluate the acceptance of TTE and TEE results and judge the clinical effects. The primary outcome is the clinical effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The quality of Transthoracic echocardiography is poor ( >3 sections cannot be obtained or the inner membrane is not clear)

2. The diagnosis of the etiology by Transthoracic ultrasonography is still unclear

3. The results of Transthoracic ultrasonography are inconsistent with clinical judgment or cannot explain the existing signs.

4. No obvious improvement or even aggravation after thoracic examination and corresponding treatment

5. Special conditions or clinical scenarios

6. Other clinicians think a TEE check is required.

Exclusion Criteria:

1. There is a tee test taboo and clinicians evaluate the risk over benefit

2. Did not sign an informed consent form

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

Diagnostic Test:
• Transesophageal echocardiography
Eligible patients would be conducted both Transesophageal echocardiography and Transthoracic echocardiography to offer independent results

Locations

Country	Name	City	State
China	Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences	Beijing
China	Xiangya Hospital Central South University	Changsha
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning
China	The First Hospital of China Medical University	Shengyang
China	Zhongnan Hospital of Wuhan University	Wuhan

Sponsors (1)

Lead Sponsor	Collaborator
Kang Yan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conclusion of the adoption	Researcher C conducted a questionnaire survey on attending physician to evaluate the effect	48 hours after completion of the examination
Secondary	adverse events	Adverse events associated with the examination,eg.1.Anesthetic allergy;2.Nausea, vomiting, choking cough or aspiration;3.Laryngeal edema and even asphyxiation;4.Severe arrhythmia;5.Esophageal perforation, bleeding, or local hematoma;6.Other accidental deaths, such as acute myocardial infarction, shock, haemorrhage and possibly even death;7.Other unpredictable contingencies or complications	completion of the examination